Breast Cancer

Compared with the standard 3-week regimen, a 1-week hypofractionated regimen of adjuvant whole-breast radiotherapy had similar efficacy and safety at 5 years of follow-up, according to the U.K. FAST-Forward trial.

The trial was designed to compare the standard regimen (40 Gy in 15 fractions over 3 weeks) with a higher-dose hypofractionated regimen (27 Gy in 5 fractions over 5 days) and a lower-dose hypofractionated regimen (26 Gy in 5 fractions over 5 days) in women who had undergone surgery for early invasive breast cancer.

The 5-year rate of ipsilateral breast tumor relapse was similar with all regimens – 2.1% with the 40-Gy regimen, 1.7% with the 27-Gy regimen, and 1.4% with the 26-Gy regimen. The 26-Gy regimen also had similar safety as the 40-Gy regimen.

These results were presented at the European Society for Radiology and Oncology 2020 Online Congress by Joanne S. Haviland, MSc, of the Institute of Cancer Research in London. Results were also published in The Lancet.

Ms. Haviland said that hypofractionated regimens are attractive because of their shorter overall treatment times, which translate to greater convenience and lower treatment costs.

The historic 5-week regimen (50 Gy in 25 fractions) has been replaced by a 3-week regimen (40 Gy in 15 fractions) in the United Kingdom and elsewhere, and ongoing efforts are exploring whether further hypofractionation can be achieved without compromising efficacy and safety.

“The FAST-Forward trial was the next step on from testing hypofractionated schedules evaluated in earlier trials, including the START trials in the early 2000s and the FAST trial, which published its 10-year results earlier this year,” Ms. Haviland explained.

FAST-Forward enrolled 4,096 women who had undergone breast-conserving surgery or mastectomy for early invasive breast cancer. The patients were randomized into the aforementioned groups for adjuvant whole-breast or chest-wall radiotherapy: 40 Gy in 15 fractions over 3 weeks, 27 Gy in 5 fractions over 5 days, or 26 Gy in 5 fractions over 5 days. Boosts were permitted for all regimens.
 

Relapse, safety, and patient reports

The median follow-up was 6 years. The 5-year rate of ipsilateral breast tumor relapse was 2.1% with the 40-Gy standard regimen, 1.7% with the 27-Gy hypofractionated regimen, and 1.4% with the 26-Gy hypofractionated regimen.

The upper bound of the 95% confidence interval for the difference comparing the hypofractionated regimens against the standard fell well within the 1.6% excess predefined for noninferiority for both the 27-Gy regimen and the 26-Gy regimen (0.9% and 0.3%, respectively).

The hazard ratio for ipsilateral breast tumor relapse, compared with the standard regimen, was 0.86 for the 27-Gy hypofractionated regimen and 0.67 for the 26-Gy hypofractionated regimen.

In terms of safety, the 5-year rate of late adverse effects of the breast or chest wall – distortion, shrinkage, induration, telangiectasia, or edema – rated as “moderate” or “marked” by clinicians was 10% with the standard regimen, 15% with the 27-Gy regimen (relative risk, 1.55 ; P < .001), and 12% with the 26-Gy regimen (RR, 1.19; P = .17).

Over the entire follow-up, women had significantly higher odds of all moderate or marked individual late adverse effects (except discomfort) with the 27-Gy regimen versus the standard regimen, whereas their odds were significantly higher only for induration and edema with the 26-Gy regimen.

However, absolute rates and risk differences between groups were small, Ms. Haviland pointed out. For example, the most common moderate or marked late adverse effect with the standard regimen was breast shrinkage, seen in 5% of patients, followed by discomfort, seen in 4%.

Patient-assessed change in breast appearance and shrinkage did not differ significantly across groups. But women in the 27-Gy group were more likely than peers in the standard regimen group to report a moderate or marked increase in breast hardness/firmness (21% vs. 14%; P = .008), and women in both the 27-Gy and 26-Gy groups were more likely to report moderate or marked breast swelling (5%; P = .007 and 4%; P = .02, respectively, vs. 2%).
 

A new standard

“We have shown noninferiority in terms of local tumor control for both 5-fraction schedules, compared with the control group of 40 Gy in 15 fractions,” Ms. Haviland summarized. “Late adverse effects in normal tissues were similar after 26 Gy in 5 fractions to 40 Gy in 15 fractions, and although rates were higher for the 27-Gy schedule, we noted that these are consistent with the historic standard of 50 Gy in 25 fractions.”

“There are obvious benefits to patients and health care systems of shorter radiotherapy treatments, particularly at the current time, and in fact, the COVID pandemic has accelerated uptake of the 26-Gy schedule around the world,” she added. “At a recent consensus meeting organized by the Royal College of Radiologists, the U.K. adopted the 26-Gy schedule as a new standard, also integrating this with partial breast irradiation, in close collaboration with the U.K. IMPORT Low trial.”

“This is very important work. I think this is one of the most important trials in the past few years. It has really changed practice,” commented session co-chair Ben Slotman, MD, PhD, of Vrije Universiteit Medical Center, Amsterdam, and AMC Amsterdam, who was not involved the trial.

Dr. Slotman wondered how extensive uptake of the new hypofractionated regimen has been. “I know it’s being used in the U.K. and the Netherlands, but do you have any idea about the rest of Europe? What do we need to make it the new standard?”

“I think there has been uptake in other countries in Europe and elsewhere around the world as well,” Ms. Haviland replied. But feedback suggests adoption has been tempered because of reservations related to the regimen’s safety in certain patient subgroups.

“We haven’t found any cause for concern in the subgroups, and also backed up by meta-analysis in the many patients randomized in the START trials,” she noted. “So I think there is very convincing evidence that it is safe as a new standard.”

FAST-Forward was sponsored by the Institute of Cancer Research and funded by the National Institute for Health Research Health Technology Assessment Programme. Ms. Haviland disclosed no conflicts of interest. Dr. Slotman has relationships with ViewRay and Varian Medical Systems.

SOURCE: Haviland J et al. ESTRO 2020, Abstract OC-0610.

Compared with the standard 3-week regimen, a 1-week hypofractionated regimen of adjuvant whole-breast radiotherapy had similar efficacy and safety at 5 years of follow-up, according to the U.K. FAST-Forward trial.

The trial was designed to compare the standard regimen (40 Gy in 15 fractions over 3 weeks) with a higher-dose hypofractionated regimen (27 Gy in 5 fractions over 5 days) and a lower-dose hypofractionated regimen (26 Gy in 5 fractions over 5 days) in women who had undergone surgery for early invasive breast cancer.

The 5-year rate of ipsilateral breast tumor relapse was similar with all regimens – 2.1% with the 40-Gy regimen, 1.7% with the 27-Gy regimen, and 1.4% with the 26-Gy regimen. The 26-Gy regimen also had similar safety as the 40-Gy regimen.

These results were presented at the European Society for Radiology and Oncology 2020 Online Congress by Joanne S. Haviland, MSc, of the Institute of Cancer Research in London. Results were also published in The Lancet.

Ms. Haviland said that hypofractionated regimens are attractive because of their shorter overall treatment times, which translate to greater convenience and lower treatment costs.

The historic 5-week regimen (50 Gy in 25 fractions) has been replaced by a 3-week regimen (40 Gy in 15 fractions) in the United Kingdom and elsewhere, and ongoing efforts are exploring whether further hypofractionation can be achieved without compromising efficacy and safety.

“The FAST-Forward trial was the next step on from testing hypofractionated schedules evaluated in earlier trials, including the START trials in the early 2000s and the FAST trial, which published its 10-year results earlier this year,” Ms. Haviland explained.

FAST-Forward enrolled 4,096 women who had undergone breast-conserving surgery or mastectomy for early invasive breast cancer. The patients were randomized into the aforementioned groups for adjuvant whole-breast or chest-wall radiotherapy: 40 Gy in 15 fractions over 3 weeks, 27 Gy in 5 fractions over 5 days, or 26 Gy in 5 fractions over 5 days. Boosts were permitted for all regimens.
 

Relapse, safety, and patient reports

The median follow-up was 6 years. The 5-year rate of ipsilateral breast tumor relapse was 2.1% with the 40-Gy standard regimen, 1.7% with the 27-Gy hypofractionated regimen, and 1.4% with the 26-Gy hypofractionated regimen.

The upper bound of the 95% confidence interval for the difference comparing the hypofractionated regimens against the standard fell well within the 1.6% excess predefined for noninferiority for both the 27-Gy regimen and the 26-Gy regimen (0.9% and 0.3%, respectively).

The hazard ratio for ipsilateral breast tumor relapse, compared with the standard regimen, was 0.86 for the 27-Gy hypofractionated regimen and 0.67 for the 26-Gy hypofractionated regimen.

In terms of safety, the 5-year rate of late adverse effects of the breast or chest wall – distortion, shrinkage, induration, telangiectasia, or edema – rated as “moderate” or “marked” by clinicians was 10% with the standard regimen, 15% with the 27-Gy regimen (relative risk, 1.55 ; P < .001), and 12% with the 26-Gy regimen (RR, 1.19; P = .17).

Over the entire follow-up, women had significantly higher odds of all moderate or marked individual late adverse effects (except discomfort) with the 27-Gy regimen versus the standard regimen, whereas their odds were significantly higher only for induration and edema with the 26-Gy regimen.

However, absolute rates and risk differences between groups were small, Ms. Haviland pointed out. For example, the most common moderate or marked late adverse effect with the standard regimen was breast shrinkage, seen in 5% of patients, followed by discomfort, seen in 4%.

Patient-assessed change in breast appearance and shrinkage did not differ significantly across groups. But women in the 27-Gy group were more likely than peers in the standard regimen group to report a moderate or marked increase in breast hardness/firmness (21% vs. 14%; P = .008), and women in both the 27-Gy and 26-Gy groups were more likely to report moderate or marked breast swelling (5%; P = .007 and 4%; P = .02, respectively, vs. 2%).
 

A new standard

“We have shown noninferiority in terms of local tumor control for both 5-fraction schedules, compared with the control group of 40 Gy in 15 fractions,” Ms. Haviland summarized. “Late adverse effects in normal tissues were similar after 26 Gy in 5 fractions to 40 Gy in 15 fractions, and although rates were higher for the 27-Gy schedule, we noted that these are consistent with the historic standard of 50 Gy in 25 fractions.”

“There are obvious benefits to patients and health care systems of shorter radiotherapy treatments, particularly at the current time, and in fact, the COVID pandemic has accelerated uptake of the 26-Gy schedule around the world,” she added. “At a recent consensus meeting organized by the Royal College of Radiologists, the U.K. adopted the 26-Gy schedule as a new standard, also integrating this with partial breast irradiation, in close collaboration with the U.K. IMPORT Low trial.”

“This is very important work. I think this is one of the most important trials in the past few years. It has really changed practice,” commented session co-chair Ben Slotman, MD, PhD, of Vrije Universiteit Medical Center, Amsterdam, and AMC Amsterdam, who was not involved the trial.

Dr. Slotman wondered how extensive uptake of the new hypofractionated regimen has been. “I know it’s being used in the U.K. and the Netherlands, but do you have any idea about the rest of Europe? What do we need to make it the new standard?”

“I think there has been uptake in other countries in Europe and elsewhere around the world as well,” Ms. Haviland replied. But feedback suggests adoption has been tempered because of reservations related to the regimen’s safety in certain patient subgroups.

“We haven’t found any cause for concern in the subgroups, and also backed up by meta-analysis in the many patients randomized in the START trials,” she noted. “So I think there is very convincing evidence that it is safe as a new standard.”

FAST-Forward was sponsored by the Institute of Cancer Research and funded by the National Institute for Health Research Health Technology Assessment Programme. Ms. Haviland disclosed no conflicts of interest. Dr. Slotman has relationships with ViewRay and Varian Medical Systems.

SOURCE: Haviland J et al. ESTRO 2020, Abstract OC-0610.

Compared with the standard 3-week regimen, a 1-week hypofractionated regimen of adjuvant whole-breast radiotherapy had similar efficacy and safety at 5 years of follow-up, according to the U.K. FAST-Forward trial.

The trial was designed to compare the standard regimen (40 Gy in 15 fractions over 3 weeks) with a higher-dose hypofractionated regimen (27 Gy in 5 fractions over 5 days) and a lower-dose hypofractionated regimen (26 Gy in 5 fractions over 5 days) in women who had undergone surgery for early invasive breast cancer.

The 5-year rate of ipsilateral breast tumor relapse was similar with all regimens – 2.1% with the 40-Gy regimen, 1.7% with the 27-Gy regimen, and 1.4% with the 26-Gy regimen. The 26-Gy regimen also had similar safety as the 40-Gy regimen.

These results were presented at the European Society for Radiology and Oncology 2020 Online Congress by Joanne S. Haviland, MSc, of the Institute of Cancer Research in London. Results were also published in The Lancet.

Ms. Haviland said that hypofractionated regimens are attractive because of their shorter overall treatment times, which translate to greater convenience and lower treatment costs.

The historic 5-week regimen (50 Gy in 25 fractions) has been replaced by a 3-week regimen (40 Gy in 15 fractions) in the United Kingdom and elsewhere, and ongoing efforts are exploring whether further hypofractionation can be achieved without compromising efficacy and safety.

“The FAST-Forward trial was the next step on from testing hypofractionated schedules evaluated in earlier trials, including the START trials in the early 2000s and the FAST trial, which published its 10-year results earlier this year,” Ms. Haviland explained.

FAST-Forward enrolled 4,096 women who had undergone breast-conserving surgery or mastectomy for early invasive breast cancer. The patients were randomized into the aforementioned groups for adjuvant whole-breast or chest-wall radiotherapy: 40 Gy in 15 fractions over 3 weeks, 27 Gy in 5 fractions over 5 days, or 26 Gy in 5 fractions over 5 days. Boosts were permitted for all regimens.
 

Relapse, safety, and patient reports

The median follow-up was 6 years. The 5-year rate of ipsilateral breast tumor relapse was 2.1% with the 40-Gy standard regimen, 1.7% with the 27-Gy hypofractionated regimen, and 1.4% with the 26-Gy hypofractionated regimen.

The upper bound of the 95% confidence interval for the difference comparing the hypofractionated regimens against the standard fell well within the 1.6% excess predefined for noninferiority for both the 27-Gy regimen and the 26-Gy regimen (0.9% and 0.3%, respectively).

The hazard ratio for ipsilateral breast tumor relapse, compared with the standard regimen, was 0.86 for the 27-Gy hypofractionated regimen and 0.67 for the 26-Gy hypofractionated regimen.

In terms of safety, the 5-year rate of late adverse effects of the breast or chest wall – distortion, shrinkage, induration, telangiectasia, or edema – rated as “moderate” or “marked” by clinicians was 10% with the standard regimen, 15% with the 27-Gy regimen (relative risk, 1.55 ; P < .001), and 12% with the 26-Gy regimen (RR, 1.19; P = .17).

Over the entire follow-up, women had significantly higher odds of all moderate or marked individual late adverse effects (except discomfort) with the 27-Gy regimen versus the standard regimen, whereas their odds were significantly higher only for induration and edema with the 26-Gy regimen.

However, absolute rates and risk differences between groups were small, Ms. Haviland pointed out. For example, the most common moderate or marked late adverse effect with the standard regimen was breast shrinkage, seen in 5% of patients, followed by discomfort, seen in 4%.

Patient-assessed change in breast appearance and shrinkage did not differ significantly across groups. But women in the 27-Gy group were more likely than peers in the standard regimen group to report a moderate or marked increase in breast hardness/firmness (21% vs. 14%; P = .008), and women in both the 27-Gy and 26-Gy groups were more likely to report moderate or marked breast swelling (5%; P = .007 and 4%; P = .02, respectively, vs. 2%).
 

A new standard

“We have shown noninferiority in terms of local tumor control for both 5-fraction schedules, compared with the control group of 40 Gy in 15 fractions,” Ms. Haviland summarized. “Late adverse effects in normal tissues were similar after 26 Gy in 5 fractions to 40 Gy in 15 fractions, and although rates were higher for the 27-Gy schedule, we noted that these are consistent with the historic standard of 50 Gy in 25 fractions.”

“There are obvious benefits to patients and health care systems of shorter radiotherapy treatments, particularly at the current time, and in fact, the COVID pandemic has accelerated uptake of the 26-Gy schedule around the world,” she added. “At a recent consensus meeting organized by the Royal College of Radiologists, the U.K. adopted the 26-Gy schedule as a new standard, also integrating this with partial breast irradiation, in close collaboration with the U.K. IMPORT Low trial.”

“This is very important work. I think this is one of the most important trials in the past few years. It has really changed practice,” commented session co-chair Ben Slotman, MD, PhD, of Vrije Universiteit Medical Center, Amsterdam, and AMC Amsterdam, who was not involved the trial.

Dr. Slotman wondered how extensive uptake of the new hypofractionated regimen has been. “I know it’s being used in the U.K. and the Netherlands, but do you have any idea about the rest of Europe? What do we need to make it the new standard?”

“I think there has been uptake in other countries in Europe and elsewhere around the world as well,” Ms. Haviland replied. But feedback suggests adoption has been tempered because of reservations related to the regimen’s safety in certain patient subgroups.

“We haven’t found any cause for concern in the subgroups, and also backed up by meta-analysis in the many patients randomized in the START trials,” she noted. “So I think there is very convincing evidence that it is safe as a new standard.”

FAST-Forward was sponsored by the Institute of Cancer Research and funded by the National Institute for Health Research Health Technology Assessment Programme. Ms. Haviland disclosed no conflicts of interest. Dr. Slotman has relationships with ViewRay and Varian Medical Systems.

SOURCE: Haviland J et al. ESTRO 2020, Abstract OC-0610.

Patients with breast cancer want accurate information on the risk of their cancer recurring once they have completed treatment.

“I would like to know the true stats of how many breast cancers come back no matter what the hell we do for treatment,” comments a typical post on a breast cancer patient bulletin board.

But those statistics have not been available from a robust population-based source.

Now, there is hope that they will – at last – be collected.

A new pilot project at the National Cancer Institute is setting out to collect that information, although the researchers say it is a “long-term goal” that will take a few years.

But it has already been a long time coming. The mother lode of all U.S. cancer data, the NCI’s Surveillance, Epidemiology, and End Results (SEER) Program, started collecting cancer data in 1973.

“When they began to capture cancer data, the focus was primarily on the incidence of cancer, the different types of cancer, and survival,” explained Esmeralda Ramirez-Pena, PhD, MPH, cancer prevention fellow at the NCI.

“Later, SEER expanded to include subgroups of various cancers and different stages at diagnosis,” she added.

But this database has never included information on cancer recurrence.

In a 2017 press statement, the NCI commented: “Collecting recurrence data has been challenging for cancer registries because recurrence can be diagnosed through diverse methods and in a variety of locations.”
 

New project

The NCI now has a “long-term goal” to implement additional “data elements” into SEER that will allow calculation of breast cancer recurrences, said Dr. Ramirez-Pena.

The Breast Cancer Recurrence Project, a pilot program funded via an NCI–Department of Energy collaboration, “will take a couple of years,” she said.

She presented some details of the new project as a poster at the recent San Antonio Breast Cancer Symposium 2020.

“SEER has added data elements over time,” she said, and this latest move will – at last – include information on breast cancer recurrence.
 

Why the change now?

“There’s been so much interest [in breast cancer recurrence]. It’s a top cause of cancer death in the United States and globally. The urgent need is evident,” she explained.

Breast cancer advocates have long been calling for SEER to count recurrence, including metastatic recurrence.

Katherine O’Brien, a breast cancer “metser” from Chicago, is credited with especially turning the heat up on the NCI.

In 2015, Ms. O’Brien spearheaded the creation of an online petition on the website change.org, calling on the NCI’s SEER, the Centers for Disease Control and Prevention, and all state cancer registries to start counting all people living with metastatic breast cancer, including those whose early-stage disease progressed. The petition, which is now closed, collected nearly 12,000 signatures.
 

Tracking recurrences

In the new project, cancer recurrence is defined as a cancer that was treated, reduced to undetectable levels, and later returned either locally, regionally, or distantly.

Tracking recurrence is not a simple matter because posttreatment surveillance to detect it includes clinical exams, biomarker testing, pathologic studies, molecular testing, imaging, and patient-reported symptoms and because recurrence frequency varies by subtype of breast cancer and TNM classification. Additionally, recurrence may depend on age at diagnosis, a variety of risk factors, treatment type, and access to quality of care.

“It’s likely there are many elements that influence recurrence,” said Dr. Ramirez-Pena.

To get a handle on the complexity, the NCI needs to first identify which data are needed to tally recurrence and the frequency at which they are collected, explained Dr. Ramirez-Pena. To do so, she and her coinvestigators conducted a systematic review of phase 3 clinical trials of early-stage breast cancer.

On their own, such trials are not sufficient to provide recurrence estimates at the population level because they lack diversity, represent fewer than 5% of all cancer patients, and the study period may not be long enough to capture recurrences for long-latency breast cancers, such as estrogen receptor–positive malignancies.

Nonetheless, these clinical trials provide a starting place.

The investigators identified 444 early-stage clinical trials. They stratified participants by subtype and tumor characteristics, which will enable analysis of risk-group and treatment-dependent differences in recurrence.

The changing science of breast cancer makes this work a challenge, the investigators said. For example, in clinical trials from the early 1990s through the early 2000s, receptor status and subtyping was not commonly reported, and some treatment endpoints were added during the past few years.

“Our next step will be to extract recurrence rates from these trials so we can eventually provide individualized information about recurrence risk to survivors,” Dr. Ramirez-Pena said, describing the big-picture aims.

The Breast Cancer Recurrence Project is collaborating with external agencies, such as the International Agency for Research on Cancer and Public Health England, in fine-tuning data elements, because “recurrence is not captured well globally either,” said Dr. Ramirez-Pena.

The study was supported by NCI.

A version of this article first appeared on Medscape.com.

Patients with breast cancer want accurate information on the risk of their cancer recurring once they have completed treatment.

“I would like to know the true stats of how many breast cancers come back no matter what the hell we do for treatment,” comments a typical post on a breast cancer patient bulletin board.

But those statistics have not been available from a robust population-based source.

Now, there is hope that they will – at last – be collected.

A new pilot project at the National Cancer Institute is setting out to collect that information, although the researchers say it is a “long-term goal” that will take a few years.

But it has already been a long time coming. The mother lode of all U.S. cancer data, the NCI’s Surveillance, Epidemiology, and End Results (SEER) Program, started collecting cancer data in 1973.

“When they began to capture cancer data, the focus was primarily on the incidence of cancer, the different types of cancer, and survival,” explained Esmeralda Ramirez-Pena, PhD, MPH, cancer prevention fellow at the NCI.

“Later, SEER expanded to include subgroups of various cancers and different stages at diagnosis,” she added.

But this database has never included information on cancer recurrence.

In a 2017 press statement, the NCI commented: “Collecting recurrence data has been challenging for cancer registries because recurrence can be diagnosed through diverse methods and in a variety of locations.”
 

New project

The NCI now has a “long-term goal” to implement additional “data elements” into SEER that will allow calculation of breast cancer recurrences, said Dr. Ramirez-Pena.

The Breast Cancer Recurrence Project, a pilot program funded via an NCI–Department of Energy collaboration, “will take a couple of years,” she said.

She presented some details of the new project as a poster at the recent San Antonio Breast Cancer Symposium 2020.

“SEER has added data elements over time,” she said, and this latest move will – at last – include information on breast cancer recurrence.
 

Why the change now?

“There’s been so much interest [in breast cancer recurrence]. It’s a top cause of cancer death in the United States and globally. The urgent need is evident,” she explained.

Breast cancer advocates have long been calling for SEER to count recurrence, including metastatic recurrence.

Katherine O’Brien, a breast cancer “metser” from Chicago, is credited with especially turning the heat up on the NCI.

In 2015, Ms. O’Brien spearheaded the creation of an online petition on the website change.org, calling on the NCI’s SEER, the Centers for Disease Control and Prevention, and all state cancer registries to start counting all people living with metastatic breast cancer, including those whose early-stage disease progressed. The petition, which is now closed, collected nearly 12,000 signatures.
 

Tracking recurrences

In the new project, cancer recurrence is defined as a cancer that was treated, reduced to undetectable levels, and later returned either locally, regionally, or distantly.

Tracking recurrence is not a simple matter because posttreatment surveillance to detect it includes clinical exams, biomarker testing, pathologic studies, molecular testing, imaging, and patient-reported symptoms and because recurrence frequency varies by subtype of breast cancer and TNM classification. Additionally, recurrence may depend on age at diagnosis, a variety of risk factors, treatment type, and access to quality of care.

“It’s likely there are many elements that influence recurrence,” said Dr. Ramirez-Pena.

To get a handle on the complexity, the NCI needs to first identify which data are needed to tally recurrence and the frequency at which they are collected, explained Dr. Ramirez-Pena. To do so, she and her coinvestigators conducted a systematic review of phase 3 clinical trials of early-stage breast cancer.

On their own, such trials are not sufficient to provide recurrence estimates at the population level because they lack diversity, represent fewer than 5% of all cancer patients, and the study period may not be long enough to capture recurrences for long-latency breast cancers, such as estrogen receptor–positive malignancies.

Nonetheless, these clinical trials provide a starting place.

The investigators identified 444 early-stage clinical trials. They stratified participants by subtype and tumor characteristics, which will enable analysis of risk-group and treatment-dependent differences in recurrence.

The changing science of breast cancer makes this work a challenge, the investigators said. For example, in clinical trials from the early 1990s through the early 2000s, receptor status and subtyping was not commonly reported, and some treatment endpoints were added during the past few years.

“Our next step will be to extract recurrence rates from these trials so we can eventually provide individualized information about recurrence risk to survivors,” Dr. Ramirez-Pena said, describing the big-picture aims.

The Breast Cancer Recurrence Project is collaborating with external agencies, such as the International Agency for Research on Cancer and Public Health England, in fine-tuning data elements, because “recurrence is not captured well globally either,” said Dr. Ramirez-Pena.

The study was supported by NCI.

A version of this article first appeared on Medscape.com.

Patients with breast cancer want accurate information on the risk of their cancer recurring once they have completed treatment.

“I would like to know the true stats of how many breast cancers come back no matter what the hell we do for treatment,” comments a typical post on a breast cancer patient bulletin board.

But those statistics have not been available from a robust population-based source.

Now, there is hope that they will – at last – be collected.

A new pilot project at the National Cancer Institute is setting out to collect that information, although the researchers say it is a “long-term goal” that will take a few years.

But it has already been a long time coming. The mother lode of all U.S. cancer data, the NCI’s Surveillance, Epidemiology, and End Results (SEER) Program, started collecting cancer data in 1973.

“When they began to capture cancer data, the focus was primarily on the incidence of cancer, the different types of cancer, and survival,” explained Esmeralda Ramirez-Pena, PhD, MPH, cancer prevention fellow at the NCI.

“Later, SEER expanded to include subgroups of various cancers and different stages at diagnosis,” she added.

But this database has never included information on cancer recurrence.

In a 2017 press statement, the NCI commented: “Collecting recurrence data has been challenging for cancer registries because recurrence can be diagnosed through diverse methods and in a variety of locations.”
 

New project

The NCI now has a “long-term goal” to implement additional “data elements” into SEER that will allow calculation of breast cancer recurrences, said Dr. Ramirez-Pena.

The Breast Cancer Recurrence Project, a pilot program funded via an NCI–Department of Energy collaboration, “will take a couple of years,” she said.

She presented some details of the new project as a poster at the recent San Antonio Breast Cancer Symposium 2020.

“SEER has added data elements over time,” she said, and this latest move will – at last – include information on breast cancer recurrence.
 

Why the change now?

“There’s been so much interest [in breast cancer recurrence]. It’s a top cause of cancer death in the United States and globally. The urgent need is evident,” she explained.

Breast cancer advocates have long been calling for SEER to count recurrence, including metastatic recurrence.

Katherine O’Brien, a breast cancer “metser” from Chicago, is credited with especially turning the heat up on the NCI.

In 2015, Ms. O’Brien spearheaded the creation of an online petition on the website change.org, calling on the NCI’s SEER, the Centers for Disease Control and Prevention, and all state cancer registries to start counting all people living with metastatic breast cancer, including those whose early-stage disease progressed. The petition, which is now closed, collected nearly 12,000 signatures.
 

Tracking recurrences

In the new project, cancer recurrence is defined as a cancer that was treated, reduced to undetectable levels, and later returned either locally, regionally, or distantly.

Tracking recurrence is not a simple matter because posttreatment surveillance to detect it includes clinical exams, biomarker testing, pathologic studies, molecular testing, imaging, and patient-reported symptoms and because recurrence frequency varies by subtype of breast cancer and TNM classification. Additionally, recurrence may depend on age at diagnosis, a variety of risk factors, treatment type, and access to quality of care.

“It’s likely there are many elements that influence recurrence,” said Dr. Ramirez-Pena.

To get a handle on the complexity, the NCI needs to first identify which data are needed to tally recurrence and the frequency at which they are collected, explained Dr. Ramirez-Pena. To do so, she and her coinvestigators conducted a systematic review of phase 3 clinical trials of early-stage breast cancer.

On their own, such trials are not sufficient to provide recurrence estimates at the population level because they lack diversity, represent fewer than 5% of all cancer patients, and the study period may not be long enough to capture recurrences for long-latency breast cancers, such as estrogen receptor–positive malignancies.

Nonetheless, these clinical trials provide a starting place.

The investigators identified 444 early-stage clinical trials. They stratified participants by subtype and tumor characteristics, which will enable analysis of risk-group and treatment-dependent differences in recurrence.

The changing science of breast cancer makes this work a challenge, the investigators said. For example, in clinical trials from the early 1990s through the early 2000s, receptor status and subtyping was not commonly reported, and some treatment endpoints were added during the past few years.

“Our next step will be to extract recurrence rates from these trials so we can eventually provide individualized information about recurrence risk to survivors,” Dr. Ramirez-Pena said, describing the big-picture aims.

The Breast Cancer Recurrence Project is collaborating with external agencies, such as the International Agency for Research on Cancer and Public Health England, in fine-tuning data elements, because “recurrence is not captured well globally either,” said Dr. Ramirez-Pena.

The study was supported by NCI.

A version of this article first appeared on Medscape.com.

Breast cancer patients treated with curative intent do not often experience symptoms related to the cancer itself, and treatment toxicities may impact adherence and subsequently prognosis. Mittendorf et al reported on patient reported outcomes (PROs) from the phase 3 IMpassion031 trial which showed pCR improvement with atezolizumab/chemotherapy compared to placebo/chemotherapy for neoadjuvant early-stage TNBC. Health-related quality of life items and treatment-related symptoms worsened similarly in both arms during neoadjuvant therapy, and recovered/stabilized in the adjuvant setting. Further exploration of immunotherapy PROs is warranted, as clinical benefit is seen with these agents and they do not appear to negatively impact functioning and patient experience with treatment long-term. Side effect profiles of immunotherapy and standard chemotherapy are different, and design of immunotherapy-specific PROs are desired.

The PRIME 2 10 year results evaluating the role of whole breast irradiation in women ≥65 years with early-stage HR-positive breast cancer receiving hormonal therapy showed RT reduced risk of local recurrence from 9.8% to 0.9% at 10 years (p=0.0008). Patients with low ER tumors had higher 10 year local recurrence rate compared to high ER tumors (18.8% versus 9.2% (p0.007)). Rates of overall survival (80.4% in no RT group vs 81.0% in RT group) and metastasis free survival were similar. A shared decision making approach is key, carefully weighing benefits and risks, considering pathologic features, patient preferences and co-morbidities that may influence endocrine therapy adherence. The impact of molecular subtypes and genomic assays is also being explored to help assess radiation benefit and guide treatment recommendations.

Breast cancer in young women presents unique challenges considering the lifetime period during which diagnosis occurs. Previous studies have supported the safety of pregnancy after breast cancer and guidelines recommend oncofertility counseling in young patients. Blondeaux et al found that breast cancer patients had a 60% lower chance of pregnancy after treatment and were more likely to have complications including low birth weight, small for gestational age, preterm delivery and cesarean section. Although increased risk of congenital abnormalities did not appear to be statistically significant, the HR was 1.63. Importantly, pregnancy after breast cancer did not negatively impact maternal outcomes. This study further supports the safety of pregnancy after breast cancer, highlights the need for close monitoring of pregnancies in these women, and emphasizes the importance of fertility and family planning discussion, which is most optimally provided in a multidisciplinary fashion.

References:

Dent R, Oliveira AM, Isakoff SJ, Im SA, Espié M, Blau S, Saura C, Wongchenko MJ, Xu N, Bradley D, Reilly SJ, Mani A, Kim SB. Final results of the double-blind placebo (PBO)-controlled randomised phase II LOTUS trial of first-line ipatasertib (IPAT) + paclitaxel (PAC) for inoperable locally advanced/metastatic triple-negative breast cancer (mTNBC). Presented during 2020 ESMO breast cancer virtual meeting; May 23-24, 2020. Abstract 139O.

Schmid P, Abraham J, Chan S, Wheatley D, Brunt AM, Nemsadze G, Baird RD, Park YH, Hall PS, Perren T, Stein RC, Mangel L, Ferrero JM, Phillips M, Conibear J, Cortes J, Foxley A, de Bruin EC, McEwen R, Stetson D, Dougherty B, Sarker SJ, Prendergast A, McLaughlin-Callan M, Burgess M, Lawrence C, Cartwright H, Mousa K, Turner NC. Capivasertib plus paclitaxel versus placebo plus paclitaxel as first-line therapy for metastatic triple-negative breast cancer: the PAKT trial. J Clin Oncol. 2020;38:423-433.

Mittendorf EA, Zhang H, Barrios CH, Saji S, Jung KH, Hegg R, Koehler A, Sohn J, Iwata H, Telli ML, Ferrario C, Punie K, Penault-Llorca F, Patel S, Duc AN, Liste-Hermoso M, Maiya V, Molinero L, Chui SY, Harbeck N. Neoadjuvant atezolizumab in combination with sequential nab-paclitaxel and anthracycline-based chemotherapy versus placebo and chemotherapy in patients with early-stage triple-negative breast cancer (IMpassion031): a randomised, double-blind, phase 3 trial. Lancet. 2020;396:1090-1100.

King-Kallimanis BL, Howie LJ, Roydhouse JK, Singh H, Theoret MR, Blumenthal GM, Kluetz PG. Patient reported outcomes in anti-PD-1/PD-L1 inhibitor immunotherapy registration trials: FDA analysis of data submitted and future directions. Clin Trials. 2019;16:322-326.

Fodor A, Brombin C, Mangili P, Borroni F, Pasetti M, Tummineri R, Zerbetto F, Longobardi B, Perna L, Dell'Oca I, Deantoni CL, Deli AM, Chiara A, Broggi S, Castriconi R, Esposito PG, Slim N, Passoni P, Baroni S, Villa SL, Rancoita PMV, Fiorino C, Del Vecchio A, Bianchini G, Gentilini OD, Di Serio MS, Di Muzio NG. Impact of molecular subtype on 1325 early-stage breast cancer patients homogeneously treated with hypofractionated radiotherapy without boost: Should the indications for radiotherapy be more personalized? Breast. 2020;55:45-54.

Azim HA Jr, Santoro L, Pavlidis N, Gelber S, Kroman N, Azim H, Peccatori FA. Safety of pregnancy following breast cancer diagnosis: a meta-analysis of 14 studies. Eur J Cancer. 2011;47:74-83.

Breast cancer patients treated with curative intent do not often experience symptoms related to the cancer itself, and treatment toxicities may impact adherence and subsequently prognosis. Mittendorf et al reported on patient reported outcomes (PROs) from the phase 3 IMpassion031 trial which showed pCR improvement with atezolizumab/chemotherapy compared to placebo/chemotherapy for neoadjuvant early-stage TNBC. Health-related quality of life items and treatment-related symptoms worsened similarly in both arms during neoadjuvant therapy, and recovered/stabilized in the adjuvant setting. Further exploration of immunotherapy PROs is warranted, as clinical benefit is seen with these agents and they do not appear to negatively impact functioning and patient experience with treatment long-term. Side effect profiles of immunotherapy and standard chemotherapy are different, and design of immunotherapy-specific PROs are desired.

The PRIME 2 10 year results evaluating the role of whole breast irradiation in women ≥65 years with early-stage HR-positive breast cancer receiving hormonal therapy showed RT reduced risk of local recurrence from 9.8% to 0.9% at 10 years (p=0.0008). Patients with low ER tumors had higher 10 year local recurrence rate compared to high ER tumors (18.8% versus 9.2% (p0.007)). Rates of overall survival (80.4% in no RT group vs 81.0% in RT group) and metastasis free survival were similar. A shared decision making approach is key, carefully weighing benefits and risks, considering pathologic features, patient preferences and co-morbidities that may influence endocrine therapy adherence. The impact of molecular subtypes and genomic assays is also being explored to help assess radiation benefit and guide treatment recommendations.

Breast cancer in young women presents unique challenges considering the lifetime period during which diagnosis occurs. Previous studies have supported the safety of pregnancy after breast cancer and guidelines recommend oncofertility counseling in young patients. Blondeaux et al found that breast cancer patients had a 60% lower chance of pregnancy after treatment and were more likely to have complications including low birth weight, small for gestational age, preterm delivery and cesarean section. Although increased risk of congenital abnormalities did not appear to be statistically significant, the HR was 1.63. Importantly, pregnancy after breast cancer did not negatively impact maternal outcomes. This study further supports the safety of pregnancy after breast cancer, highlights the need for close monitoring of pregnancies in these women, and emphasizes the importance of fertility and family planning discussion, which is most optimally provided in a multidisciplinary fashion.

References:

Dent R, Oliveira AM, Isakoff SJ, Im SA, Espié M, Blau S, Saura C, Wongchenko MJ, Xu N, Bradley D, Reilly SJ, Mani A, Kim SB. Final results of the double-blind placebo (PBO)-controlled randomised phase II LOTUS trial of first-line ipatasertib (IPAT) + paclitaxel (PAC) for inoperable locally advanced/metastatic triple-negative breast cancer (mTNBC). Presented during 2020 ESMO breast cancer virtual meeting; May 23-24, 2020. Abstract 139O.

Schmid P, Abraham J, Chan S, Wheatley D, Brunt AM, Nemsadze G, Baird RD, Park YH, Hall PS, Perren T, Stein RC, Mangel L, Ferrero JM, Phillips M, Conibear J, Cortes J, Foxley A, de Bruin EC, McEwen R, Stetson D, Dougherty B, Sarker SJ, Prendergast A, McLaughlin-Callan M, Burgess M, Lawrence C, Cartwright H, Mousa K, Turner NC. Capivasertib plus paclitaxel versus placebo plus paclitaxel as first-line therapy for metastatic triple-negative breast cancer: the PAKT trial. J Clin Oncol. 2020;38:423-433.

Mittendorf EA, Zhang H, Barrios CH, Saji S, Jung KH, Hegg R, Koehler A, Sohn J, Iwata H, Telli ML, Ferrario C, Punie K, Penault-Llorca F, Patel S, Duc AN, Liste-Hermoso M, Maiya V, Molinero L, Chui SY, Harbeck N. Neoadjuvant atezolizumab in combination with sequential nab-paclitaxel and anthracycline-based chemotherapy versus placebo and chemotherapy in patients with early-stage triple-negative breast cancer (IMpassion031): a randomised, double-blind, phase 3 trial. Lancet. 2020;396:1090-1100.

King-Kallimanis BL, Howie LJ, Roydhouse JK, Singh H, Theoret MR, Blumenthal GM, Kluetz PG. Patient reported outcomes in anti-PD-1/PD-L1 inhibitor immunotherapy registration trials: FDA analysis of data submitted and future directions. Clin Trials. 2019;16:322-326.

Fodor A, Brombin C, Mangili P, Borroni F, Pasetti M, Tummineri R, Zerbetto F, Longobardi B, Perna L, Dell'Oca I, Deantoni CL, Deli AM, Chiara A, Broggi S, Castriconi R, Esposito PG, Slim N, Passoni P, Baroni S, Villa SL, Rancoita PMV, Fiorino C, Del Vecchio A, Bianchini G, Gentilini OD, Di Serio MS, Di Muzio NG. Impact of molecular subtype on 1325 early-stage breast cancer patients homogeneously treated with hypofractionated radiotherapy without boost: Should the indications for radiotherapy be more personalized? Breast. 2020;55:45-54.

Azim HA Jr, Santoro L, Pavlidis N, Gelber S, Kroman N, Azim H, Peccatori FA. Safety of pregnancy following breast cancer diagnosis: a meta-analysis of 14 studies. Eur J Cancer. 2011;47:74-83.

Breast cancer patients treated with curative intent do not often experience symptoms related to the cancer itself, and treatment toxicities may impact adherence and subsequently prognosis. Mittendorf et al reported on patient reported outcomes (PROs) from the phase 3 IMpassion031 trial which showed pCR improvement with atezolizumab/chemotherapy compared to placebo/chemotherapy for neoadjuvant early-stage TNBC. Health-related quality of life items and treatment-related symptoms worsened similarly in both arms during neoadjuvant therapy, and recovered/stabilized in the adjuvant setting. Further exploration of immunotherapy PROs is warranted, as clinical benefit is seen with these agents and they do not appear to negatively impact functioning and patient experience with treatment long-term. Side effect profiles of immunotherapy and standard chemotherapy are different, and design of immunotherapy-specific PROs are desired.

The PRIME 2 10 year results evaluating the role of whole breast irradiation in women ≥65 years with early-stage HR-positive breast cancer receiving hormonal therapy showed RT reduced risk of local recurrence from 9.8% to 0.9% at 10 years (p=0.0008). Patients with low ER tumors had higher 10 year local recurrence rate compared to high ER tumors (18.8% versus 9.2% (p0.007)). Rates of overall survival (80.4% in no RT group vs 81.0% in RT group) and metastasis free survival were similar. A shared decision making approach is key, carefully weighing benefits and risks, considering pathologic features, patient preferences and co-morbidities that may influence endocrine therapy adherence. The impact of molecular subtypes and genomic assays is also being explored to help assess radiation benefit and guide treatment recommendations.

Breast cancer in young women presents unique challenges considering the lifetime period during which diagnosis occurs. Previous studies have supported the safety of pregnancy after breast cancer and guidelines recommend oncofertility counseling in young patients. Blondeaux et al found that breast cancer patients had a 60% lower chance of pregnancy after treatment and were more likely to have complications including low birth weight, small for gestational age, preterm delivery and cesarean section. Although increased risk of congenital abnormalities did not appear to be statistically significant, the HR was 1.63. Importantly, pregnancy after breast cancer did not negatively impact maternal outcomes. This study further supports the safety of pregnancy after breast cancer, highlights the need for close monitoring of pregnancies in these women, and emphasizes the importance of fertility and family planning discussion, which is most optimally provided in a multidisciplinary fashion.

References:

Dent R, Oliveira AM, Isakoff SJ, Im SA, Espié M, Blau S, Saura C, Wongchenko MJ, Xu N, Bradley D, Reilly SJ, Mani A, Kim SB. Final results of the double-blind placebo (PBO)-controlled randomised phase II LOTUS trial of first-line ipatasertib (IPAT) + paclitaxel (PAC) for inoperable locally advanced/metastatic triple-negative breast cancer (mTNBC). Presented during 2020 ESMO breast cancer virtual meeting; May 23-24, 2020. Abstract 139O.

Schmid P, Abraham J, Chan S, Wheatley D, Brunt AM, Nemsadze G, Baird RD, Park YH, Hall PS, Perren T, Stein RC, Mangel L, Ferrero JM, Phillips M, Conibear J, Cortes J, Foxley A, de Bruin EC, McEwen R, Stetson D, Dougherty B, Sarker SJ, Prendergast A, McLaughlin-Callan M, Burgess M, Lawrence C, Cartwright H, Mousa K, Turner NC. Capivasertib plus paclitaxel versus placebo plus paclitaxel as first-line therapy for metastatic triple-negative breast cancer: the PAKT trial. J Clin Oncol. 2020;38:423-433.

Mittendorf EA, Zhang H, Barrios CH, Saji S, Jung KH, Hegg R, Koehler A, Sohn J, Iwata H, Telli ML, Ferrario C, Punie K, Penault-Llorca F, Patel S, Duc AN, Liste-Hermoso M, Maiya V, Molinero L, Chui SY, Harbeck N. Neoadjuvant atezolizumab in combination with sequential nab-paclitaxel and anthracycline-based chemotherapy versus placebo and chemotherapy in patients with early-stage triple-negative breast cancer (IMpassion031): a randomised, double-blind, phase 3 trial. Lancet. 2020;396:1090-1100.

King-Kallimanis BL, Howie LJ, Roydhouse JK, Singh H, Theoret MR, Blumenthal GM, Kluetz PG. Patient reported outcomes in anti-PD-1/PD-L1 inhibitor immunotherapy registration trials: FDA analysis of data submitted and future directions. Clin Trials. 2019;16:322-326.

Fodor A, Brombin C, Mangili P, Borroni F, Pasetti M, Tummineri R, Zerbetto F, Longobardi B, Perna L, Dell'Oca I, Deantoni CL, Deli AM, Chiara A, Broggi S, Castriconi R, Esposito PG, Slim N, Passoni P, Baroni S, Villa SL, Rancoita PMV, Fiorino C, Del Vecchio A, Bianchini G, Gentilini OD, Di Serio MS, Di Muzio NG. Impact of molecular subtype on 1325 early-stage breast cancer patients homogeneously treated with hypofractionated radiotherapy without boost: Should the indications for radiotherapy be more personalized? Breast. 2020;55:45-54.

Azim HA Jr, Santoro L, Pavlidis N, Gelber S, Kroman N, Azim H, Peccatori FA. Safety of pregnancy following breast cancer diagnosis: a meta-analysis of 14 studies. Eur J Cancer. 2011;47:74-83.

Key clinical point: Omitting adjuvant radiotherapy may be an option for some older women with low-risk, hormone receptor-positive breast cancer who are receiving appropriate endocrine treatment.

Major finding: The 10-year rate of ipsilateral recurrence was lower with radiotherapy than without (0.9% vs. 9.8%, P = .00008), but there was no significant between-arm difference in 10-year overall survival (81.0% and 80.4%, respectively; P = .68).

Study details: A phase 3, randomized trial of 1,326 women age 65 and older with hormone receptor–positive, low-risk early breast cancer undergoing breast-conserving surgery and receiving adjuvant endocrine therapy with or without whole breast irradiation (40-50 Gy in 15-25 fractions).

Disclosures: The study was funded by the Chief Scientist Office (Scottish Government) and the Breast Cancer Institute at the Western General Hospital in Edinburgh, Scotland. Dr. Kunkler did not have any disclosures.

Source: Kunkler IH J et al. SABCS 2020, Abstract GS2-03.

Key clinical point: Omitting adjuvant radiotherapy may be an option for some older women with low-risk, hormone receptor-positive breast cancer who are receiving appropriate endocrine treatment.

Major finding: The 10-year rate of ipsilateral recurrence was lower with radiotherapy than without (0.9% vs. 9.8%, P = .00008), but there was no significant between-arm difference in 10-year overall survival (81.0% and 80.4%, respectively; P = .68).

Study details: A phase 3, randomized trial of 1,326 women age 65 and older with hormone receptor–positive, low-risk early breast cancer undergoing breast-conserving surgery and receiving adjuvant endocrine therapy with or without whole breast irradiation (40-50 Gy in 15-25 fractions).

Disclosures: The study was funded by the Chief Scientist Office (Scottish Government) and the Breast Cancer Institute at the Western General Hospital in Edinburgh, Scotland. Dr. Kunkler did not have any disclosures.

Source: Kunkler IH J et al. SABCS 2020, Abstract GS2-03.

Key clinical point: Omitting adjuvant radiotherapy may be an option for some older women with low-risk, hormone receptor-positive breast cancer who are receiving appropriate endocrine treatment.

Major finding: The 10-year rate of ipsilateral recurrence was lower with radiotherapy than without (0.9% vs. 9.8%, P = .00008), but there was no significant between-arm difference in 10-year overall survival (81.0% and 80.4%, respectively; P = .68).

Study details: A phase 3, randomized trial of 1,326 women age 65 and older with hormone receptor–positive, low-risk early breast cancer undergoing breast-conserving surgery and receiving adjuvant endocrine therapy with or without whole breast irradiation (40-50 Gy in 15-25 fractions).

Disclosures: The study was funded by the Chief Scientist Office (Scottish Government) and the Breast Cancer Institute at the Western General Hospital in Edinburgh, Scotland. Dr. Kunkler did not have any disclosures.

Source: Kunkler IH J et al. SABCS 2020, Abstract GS2-03.

Key clinical point: One year of palbociclib added to endocrine therapy after neoadjuvant chemotherapy did not improve invasive disease-free survival when compared with placebo plus endocrine therapy in women with hormone receptor–positive, HER2-negative primary breast cancer.

Major finding: The 4-year invasive disease-free survival rate was 73.0% for palbociclib and 72.4% for placebo (hazard ratio, 0.93; P = .525).

Study details: A phase 3 trial of 1,250 women with hormone receptor–positive, HER2-negative primary breast cancer who were at high risk of relapse after neoadjuvant chemotherapy.

Disclosures: The trial was sponsored by the German Breast Group in collaboration with Pfizer, the AGO Study Group, NSABP Foundation, and the Breast International Group. Dr. Loibl disclosed grant and other support from Pfizer during the conduct of the study, relationships with other companies outside the submitted work, a pending patent for a method to predict response to anti-HER2–containing therapy and/or chemotherapy, and a relationship with Medscape, which is owned by the same company as MDedge.

Source: Loibl S et al. SABCS 2020, Abstract GS1-02.

Key clinical point: One year of palbociclib added to endocrine therapy after neoadjuvant chemotherapy did not improve invasive disease-free survival when compared with placebo plus endocrine therapy in women with hormone receptor–positive, HER2-negative primary breast cancer.

Major finding: The 4-year invasive disease-free survival rate was 73.0% for palbociclib and 72.4% for placebo (hazard ratio, 0.93; P = .525).

Study details: A phase 3 trial of 1,250 women with hormone receptor–positive, HER2-negative primary breast cancer who were at high risk of relapse after neoadjuvant chemotherapy.

Disclosures: The trial was sponsored by the German Breast Group in collaboration with Pfizer, the AGO Study Group, NSABP Foundation, and the Breast International Group. Dr. Loibl disclosed grant and other support from Pfizer during the conduct of the study, relationships with other companies outside the submitted work, a pending patent for a method to predict response to anti-HER2–containing therapy and/or chemotherapy, and a relationship with Medscape, which is owned by the same company as MDedge.

Source: Loibl S et al. SABCS 2020, Abstract GS1-02.

Key clinical point: One year of palbociclib added to endocrine therapy after neoadjuvant chemotherapy did not improve invasive disease-free survival when compared with placebo plus endocrine therapy in women with hormone receptor–positive, HER2-negative primary breast cancer.

Major finding: The 4-year invasive disease-free survival rate was 73.0% for palbociclib and 72.4% for placebo (hazard ratio, 0.93; P = .525).

Study details: A phase 3 trial of 1,250 women with hormone receptor–positive, HER2-negative primary breast cancer who were at high risk of relapse after neoadjuvant chemotherapy.

Disclosures: The trial was sponsored by the German Breast Group in collaboration with Pfizer, the AGO Study Group, NSABP Foundation, and the Breast International Group. Dr. Loibl disclosed grant and other support from Pfizer during the conduct of the study, relationships with other companies outside the submitted work, a pending patent for a method to predict response to anti-HER2–containing therapy and/or chemotherapy, and a relationship with Medscape, which is owned by the same company as MDedge.

Source: Loibl S et al. SABCS 2020, Abstract GS1-02.

Key clinical point: Diet may influence breast cancer outcomes.

Major finding: Women who adhered to the healthiest diet had a 31% lower risk for all-cause mortality versus women in the lowest tier for dietary health.

Study details: A retrospective study of 8,320 women with breast cancer in the first and second Nurses’ Health Studies.

Disclosures: This research was supported, in part, by grants from the National Cancer Institute, Breast Cancer Research Foundations, and Susan G. Komen Breast Cancer Foundations. Dr. Wang reported no relevant conflicts of interest.

Source: Wang T et al. SABCS 2020, Abstract GS2-09.

Key clinical point: Diet may influence breast cancer outcomes.

Major finding: Women who adhered to the healthiest diet had a 31% lower risk for all-cause mortality versus women in the lowest tier for dietary health.

Study details: A retrospective study of 8,320 women with breast cancer in the first and second Nurses’ Health Studies.

Disclosures: This research was supported, in part, by grants from the National Cancer Institute, Breast Cancer Research Foundations, and Susan G. Komen Breast Cancer Foundations. Dr. Wang reported no relevant conflicts of interest.

Source: Wang T et al. SABCS 2020, Abstract GS2-09.

Key clinical point: Diet may influence breast cancer outcomes.

Major finding: Women who adhered to the healthiest diet had a 31% lower risk for all-cause mortality versus women in the lowest tier for dietary health.

Study details: A retrospective study of 8,320 women with breast cancer in the first and second Nurses’ Health Studies.

Disclosures: This research was supported, in part, by grants from the National Cancer Institute, Breast Cancer Research Foundations, and Susan G. Komen Breast Cancer Foundations. Dr. Wang reported no relevant conflicts of interest.

Source: Wang T et al. SABCS 2020, Abstract GS2-09.

Key clinical point: Breast cancer survivors are less likely to conceive and have more complications when they do, but pregnancy does not increase the risk of cancer recurrence, a review suggests.

Major finding: Relative to the general population, breast cancer survivors were 60% less likely to become pregnant, and they had higher odds of complications such as preterm birth (45% higher) and low birth weight (50% higher), but their risk of cancer recurrence was not increased.

Study details: A systematic review and meta-analysis using data from 39 studies that included a total of 114,573 breast cancer patients and 8,093,401 women from the general population.

Disclosures: The study was funded by the Italian Ministry of Health and the Italian Association for Cancer Research. Dr. Blondeaux disclosed no conflicts of interest.

Source: Blondeaux et al. SABCS 2020, Abstract GS3-09.

Key clinical point: Breast cancer survivors are less likely to conceive and have more complications when they do, but pregnancy does not increase the risk of cancer recurrence, a review suggests.

Major finding: Relative to the general population, breast cancer survivors were 60% less likely to become pregnant, and they had higher odds of complications such as preterm birth (45% higher) and low birth weight (50% higher), but their risk of cancer recurrence was not increased.

Study details: A systematic review and meta-analysis using data from 39 studies that included a total of 114,573 breast cancer patients and 8,093,401 women from the general population.

Disclosures: The study was funded by the Italian Ministry of Health and the Italian Association for Cancer Research. Dr. Blondeaux disclosed no conflicts of interest.

Source: Blondeaux et al. SABCS 2020, Abstract GS3-09.

Key clinical point: Breast cancer survivors are less likely to conceive and have more complications when they do, but pregnancy does not increase the risk of cancer recurrence, a review suggests.

Major finding: Relative to the general population, breast cancer survivors were 60% less likely to become pregnant, and they had higher odds of complications such as preterm birth (45% higher) and low birth weight (50% higher), but their risk of cancer recurrence was not increased.

Study details: A systematic review and meta-analysis using data from 39 studies that included a total of 114,573 breast cancer patients and 8,093,401 women from the general population.

Disclosures: The study was funded by the Italian Ministry of Health and the Italian Association for Cancer Research. Dr. Blondeaux disclosed no conflicts of interest.

Source: Blondeaux et al. SABCS 2020, Abstract GS3-09.

Key clinical point: Adding immunotherapy to chemotherapy for early triple-negative breast cancer did not increase symptom burden.

Major finding: Health-related quality-of-life measures were similar whether patients received chemotherapy with atezolizumab or with placebo. For example, mean physical function scores were about 90% in both treatment arms at baseline, dropped to about 65% in each arm by cycle 5, and rebounded to about 80% by cycle 7.

Study details: Exploratory patient-reported outcomes from 328 patients in the phase 3 IMpassion031 trial.

Disclosures: IMpassion031 is sponsored by F. Hoffman-LaRoche. Dr. Mittendorf disclosed relationships with Roche/Genentech, GlaxoSmithKline, Physicians’ Education Resource, AstraZeneca, Exact Sciences, Merck, Peregrine Pharmaceuticals, SELLAS Life Sciences, TapImmune, EMD Serono, Galena Biopharma, Bristol Myers Squibb, and Lilly.

Source: Mittendorf E at al. SABCS 2020, Abstract GS3-02.

Key clinical point: Adding immunotherapy to chemotherapy for early triple-negative breast cancer did not increase symptom burden.

Major finding: Health-related quality-of-life measures were similar whether patients received chemotherapy with atezolizumab or with placebo. For example, mean physical function scores were about 90% in both treatment arms at baseline, dropped to about 65% in each arm by cycle 5, and rebounded to about 80% by cycle 7.

Study details: Exploratory patient-reported outcomes from 328 patients in the phase 3 IMpassion031 trial.

Disclosures: IMpassion031 is sponsored by F. Hoffman-LaRoche. Dr. Mittendorf disclosed relationships with Roche/Genentech, GlaxoSmithKline, Physicians’ Education Resource, AstraZeneca, Exact Sciences, Merck, Peregrine Pharmaceuticals, SELLAS Life Sciences, TapImmune, EMD Serono, Galena Biopharma, Bristol Myers Squibb, and Lilly.

Source: Mittendorf E at al. SABCS 2020, Abstract GS3-02.

Key clinical point: Adding immunotherapy to chemotherapy for early triple-negative breast cancer did not increase symptom burden.

Major finding: Health-related quality-of-life measures were similar whether patients received chemotherapy with atezolizumab or with placebo. For example, mean physical function scores were about 90% in both treatment arms at baseline, dropped to about 65% in each arm by cycle 5, and rebounded to about 80% by cycle 7.

Study details: Exploratory patient-reported outcomes from 328 patients in the phase 3 IMpassion031 trial.

Disclosures: IMpassion031 is sponsored by F. Hoffman-LaRoche. Dr. Mittendorf disclosed relationships with Roche/Genentech, GlaxoSmithKline, Physicians’ Education Resource, AstraZeneca, Exact Sciences, Merck, Peregrine Pharmaceuticals, SELLAS Life Sciences, TapImmune, EMD Serono, Galena Biopharma, Bristol Myers Squibb, and Lilly.

Source: Mittendorf E at al. SABCS 2020, Abstract GS3-02.

Key clinical point: Comorbid depression, sleep disorders, or their combination is associated with early mortality in women with breast cancer.

Major finding: Depression (adjusted hazard ratio [aHR], 1.44; 95% confidence interval [CI], 1.17-1.78) and sleep disorders (aHR, 1.37; 95% CI, 1.02-1.84) were significantly associated with an increase in 5-year mortality. For the combination of depression and sleep disorders, aHR was 1.75 (95% CI: 1.17-2.60).

Study details: The data come from a retrospective cohort study of women diagnosed with breast cancer (2008-2012) in 1 of 200 general practices in the UK (n = 6,656; age, 18-80 years).

Disclosures: The study did not receive any funding. The authors declared no conflicts of interest.

Source: Bach L et al. J Psychiatr Res. 2020 Nov 23. doi: 10.1016/j.jpsychires.2020.11.036.

Key clinical point: Comorbid depression, sleep disorders, or their combination is associated with early mortality in women with breast cancer.

Major finding: Depression (adjusted hazard ratio [aHR], 1.44; 95% confidence interval [CI], 1.17-1.78) and sleep disorders (aHR, 1.37; 95% CI, 1.02-1.84) were significantly associated with an increase in 5-year mortality. For the combination of depression and sleep disorders, aHR was 1.75 (95% CI: 1.17-2.60).

Study details: The data come from a retrospective cohort study of women diagnosed with breast cancer (2008-2012) in 1 of 200 general practices in the UK (n = 6,656; age, 18-80 years).

Disclosures: The study did not receive any funding. The authors declared no conflicts of interest.

Source: Bach L et al. J Psychiatr Res. 2020 Nov 23. doi: 10.1016/j.jpsychires.2020.11.036.

Key clinical point: Comorbid depression, sleep disorders, or their combination is associated with early mortality in women with breast cancer.

Major finding: Depression (adjusted hazard ratio [aHR], 1.44; 95% confidence interval [CI], 1.17-1.78) and sleep disorders (aHR, 1.37; 95% CI, 1.02-1.84) were significantly associated with an increase in 5-year mortality. For the combination of depression and sleep disorders, aHR was 1.75 (95% CI: 1.17-2.60).

Study details: The data come from a retrospective cohort study of women diagnosed with breast cancer (2008-2012) in 1 of 200 general practices in the UK (n = 6,656; age, 18-80 years).

Disclosures: The study did not receive any funding. The authors declared no conflicts of interest.

Source: Bach L et al. J Psychiatr Res. 2020 Nov 23. doi: 10.1016/j.jpsychires.2020.11.036.

Key clinical point: Underweight appears as an independent negative prognostic factor for both overall survival (OS) and first-line progression-free survival (PFS) in women with metastatic breast cancer (MBC). In contrast, overweight and obesity are not associated with poorer outcomes.

Major finding: The median OS was 47.4 months (median follow-up, 48.6 months). Underweight (body mass index [BMI], less than 18.5 kg/m²) showed an independent association with worse OS (median OS, 33 months; hazard ratio [HR ], 1.14; 95% confidence interval [CI], 1.02-1.28) and first-line PFS (HR, 1.11; 95% CI, 1.01-1.22). Overweight (BMI, 25.0-29.9 kg/m²) or obesity (BMI, 30.0 kg/m² or higher) had no impact on OS.

Study details: This study evaluated the impact of BMI on survival outcomes among patients with metastatic breast cancer (n = 12,999) in the ESME-MBC cohort (median BMI, 24.9 kg/m²; 20% of women were obese and 5% underweight).

Disclosures: The ESME MBC database receives financial support from an industrial consortium (Roche, Pfizer, AstraZeneca, MSD, Eisai, and Daiichi Sankyo). Dr. K Saleh had no disclosures. Some of his coinvestigators reported ties with pharmaceutical companies.

Source: Saleh K et al. Breast. 2020 Dec 1. doi: 10.1016/j.breast.2020.11.014.

Key clinical point: Underweight appears as an independent negative prognostic factor for both overall survival (OS) and first-line progression-free survival (PFS) in women with metastatic breast cancer (MBC). In contrast, overweight and obesity are not associated with poorer outcomes.

Major finding: The median OS was 47.4 months (median follow-up, 48.6 months). Underweight (body mass index [BMI], less than 18.5 kg/m²) showed an independent association with worse OS (median OS, 33 months; hazard ratio [HR ], 1.14; 95% confidence interval [CI], 1.02-1.28) and first-line PFS (HR, 1.11; 95% CI, 1.01-1.22). Overweight (BMI, 25.0-29.9 kg/m²) or obesity (BMI, 30.0 kg/m² or higher) had no impact on OS.

Study details: This study evaluated the impact of BMI on survival outcomes among patients with metastatic breast cancer (n = 12,999) in the ESME-MBC cohort (median BMI, 24.9 kg/m²; 20% of women were obese and 5% underweight).

Disclosures: The ESME MBC database receives financial support from an industrial consortium (Roche, Pfizer, AstraZeneca, MSD, Eisai, and Daiichi Sankyo). Dr. K Saleh had no disclosures. Some of his coinvestigators reported ties with pharmaceutical companies.

Source: Saleh K et al. Breast. 2020 Dec 1. doi: 10.1016/j.breast.2020.11.014.

Key clinical point: Underweight appears as an independent negative prognostic factor for both overall survival (OS) and first-line progression-free survival (PFS) in women with metastatic breast cancer (MBC). In contrast, overweight and obesity are not associated with poorer outcomes.

Major finding: The median OS was 47.4 months (median follow-up, 48.6 months). Underweight (body mass index [BMI], less than 18.5 kg/m²) showed an independent association with worse OS (median OS, 33 months; hazard ratio [HR ], 1.14; 95% confidence interval [CI], 1.02-1.28) and first-line PFS (HR, 1.11; 95% CI, 1.01-1.22). Overweight (BMI, 25.0-29.9 kg/m²) or obesity (BMI, 30.0 kg/m² or higher) had no impact on OS.

Study details: This study evaluated the impact of BMI on survival outcomes among patients with metastatic breast cancer (n = 12,999) in the ESME-MBC cohort (median BMI, 24.9 kg/m²; 20% of women were obese and 5% underweight).

Disclosures: The ESME MBC database receives financial support from an industrial consortium (Roche, Pfizer, AstraZeneca, MSD, Eisai, and Daiichi Sankyo). Dr. K Saleh had no disclosures. Some of his coinvestigators reported ties with pharmaceutical companies.

Source: Saleh K et al. Breast. 2020 Dec 1. doi: 10.1016/j.breast.2020.11.014.