T h e N E W E N G L A N D J O U R N A L of M E D I C I N E
Treatm ent o f HER2-Positive Metastatic Breast Cancer Swain and colleagues (Feb. 19 issue)1 report an important overall survival ben efit of 15.7 months for the addition o f pertuzumab to trastuzumab and docetaxel as first-line treatment o f metastatic breast cancer that is positive for human epidermal growth factor re ceptor 2 (HER2). The study included a large pro portion o f patients who did not receive adjuvant or neoadjuvant trastuzumab, which is in contrast with current clinical practice in most countries. It will be informative to know the overall survival specifically in patients who received adjuvant or neoadjuvant trastuzumab and the absolute im provement by adding pertuzumab, because this result may well differ from the reported 15.7 months.
t o t h e e d it o r :
Mette S. van Ramshorst, M.D. Gabe S. Sonke, M.D., Ph.D. Netherlands Cancer Institute Amsterdam, the Netherlands [email protected]
Dr. Sonke reports receiving an unrestricted institutional re search grant from Roche Netherlands. No other potential con flict of interest relevant to this letter was reported. 1. Swain SM, Baselga J, Kim S-B, et al. Pertuzumab, trastuzu mab, and docetaxel in HER2-positive metastatic breast cancer. N Engl J Med 2015;372:724-34. DOI: 10.1056/NEJMcl503446
THIS WEEK’S LETTERS
1964
In response to van Ramshorst and Sonke regarding outcomes in the sub group of 88 patients with prior trastuzumab treatment for early breast cancer: the hazard ratio for death from any cause favored the pertuzumab group (in which patients received pertuzumab, trastuzumab, and docetaxel; hazard ratio, 0.80; 95% confidence interval, 0.44 to 1.47); owing to the small number of patients, the confidence in tervals were wide. The median overall survival was 46.6 months among 41 patients in the con trol group (in which patients received placebo, trastuzumab, and docetaxel) and 53.8 months among 47 patients in the pertuzumab group. Although the proportion o f patients with prior trastuzumab treatment was lower in our study than in current clinical practice, historical context is important. Study recruitment began less than 2 years after the initial approval of adjuvant trastuzumab. Ongoing improvements in early breast cancer therapy have lowered re currence rates and increased the proportion of patients with new metastatic breast cancer.1 The observational trial registHER2 recruited patients before the widespread use of trastuzumab in early breast cancer and reported fewer patients with new metastatic breast cancer than the more recent Systemic Therapies for HER2-Positive Metastatic Breast Cancer Registry (SystHERs) trial1 (32.0% vs. 49.2%). These findings empha size the relevance of our study data to current clinical practice.
t h e a u t h o r s reply :
1964
Treatment o f HER2-Positive Metastatic Breast Cancer
1965
A Device to Narrow the Coronary Sinus for Angina
1968
Acid-Base Problems in Diabetic Ketoacidosis
MedStar Washington Hospital Center Washington, DC [email protected]
1970
More on Sweet’s Syndrome in Patients with MDS and MEFV Mutations
Roche Products Welwyn Garden City, United Kingdom
1972
The Cost o f Drug Development
Sandra M. Swain, M.D.
Emma Clark, M.Sc.
Jose Baselga, M.D., Ph.D. Memorial Sloan Kettering Cancer Center New York, NY
N
ENGLJ
MED 372120
N E JM .O R G
MAY 1 4 ,2 0 1 5
Copyright © Massachusetts Medical Society 2015.
Treatm ent o f HER2-Positive Metastatic Breast Cancer Swain and colleagues (Feb. 19 issue)1 report an important overall survival ben efit of 15.7 months for the addition o f pertuzumab to trastuzumab and docetaxel as first-line treatment o f metastatic breast cancer that is positive for human epidermal growth factor re ceptor 2 (HER2). The study included a large pro portion o f patients who did not receive adjuvant or neoadjuvant trastuzumab, which is in contrast with current clinical practice in most countries. It will be informative to know the overall survival specifically in patients who received adjuvant or neoadjuvant trastuzumab and the absolute im provement by adding pertuzumab, because this result may well differ from the reported 15.7 months.
t o t h e e d it o r :
Mette S. van Ramshorst, M.D. Gabe S. Sonke, M.D., Ph.D. Netherlands Cancer Institute Amsterdam, the Netherlands [email protected]
Dr. Sonke reports receiving an unrestricted institutional re search grant from Roche Netherlands. No other potential con flict of interest relevant to this letter was reported. 1. Swain SM, Baselga J, Kim S-B, et al. Pertuzumab, trastuzu mab, and docetaxel in HER2-positive metastatic breast cancer. N Engl J Med 2015;372:724-34. DOI: 10.1056/NEJMcl503446
THIS WEEK’S LETTERS
1964
In response to van Ramshorst and Sonke regarding outcomes in the sub group of 88 patients with prior trastuzumab treatment for early breast cancer: the hazard ratio for death from any cause favored the pertuzumab group (in which patients received pertuzumab, trastuzumab, and docetaxel; hazard ratio, 0.80; 95% confidence interval, 0.44 to 1.47); owing to the small number of patients, the confidence in tervals were wide. The median overall survival was 46.6 months among 41 patients in the con trol group (in which patients received placebo, trastuzumab, and docetaxel) and 53.8 months among 47 patients in the pertuzumab group. Although the proportion o f patients with prior trastuzumab treatment was lower in our study than in current clinical practice, historical context is important. Study recruitment began less than 2 years after the initial approval of adjuvant trastuzumab. Ongoing improvements in early breast cancer therapy have lowered re currence rates and increased the proportion of patients with new metastatic breast cancer.1 The observational trial registHER2 recruited patients before the widespread use of trastuzumab in early breast cancer and reported fewer patients with new metastatic breast cancer than the more recent Systemic Therapies for HER2-Positive Metastatic Breast Cancer Registry (SystHERs) trial1 (32.0% vs. 49.2%). These findings empha size the relevance of our study data to current clinical practice.
t h e a u t h o r s reply :
1964
Treatment o f HER2-Positive Metastatic Breast Cancer
1965
A Device to Narrow the Coronary Sinus for Angina
1968
Acid-Base Problems in Diabetic Ketoacidosis
MedStar Washington Hospital Center Washington, DC [email protected]
1970
More on Sweet’s Syndrome in Patients with MDS and MEFV Mutations
Roche Products Welwyn Garden City, United Kingdom
1972
The Cost o f Drug Development
Sandra M. Swain, M.D.
Emma Clark, M.Sc.
Jose Baselga, M.D., Ph.D. Memorial Sloan Kettering Cancer Center New York, NY
N
ENGLJ
MED 372120
N E JM .O R G
MAY 1 4 ,2 0 1 5
Copyright © Massachusetts Medical Society 2015.
