The DOI matches its Crossref record; 22 of the 22 references it cites were found in a registry or an index.
Randomized Phase III Trial of Weekly Compared With Every-3-Weeks Paclitaxel for Metastatic Breast Cancer, With Trastuzumab for all HER-2 Overexpressors and Random Assignment to Trastuzumab or Not in HER-2 Nonoverexpressors: Final Results of Cancer and Leukemia Group B Protocol 9840
Open accessAbstract
Purpose: Phase II trials suggested that weekly paclitaxel might be more effective and less toxic than every-3-weeks administration for metastatic breast cancer (MBC). Cancer and Leukemia Group B (CALGB) protocol 9840 was initiated to address this question. Subsequently trastuzumab was demonstrated to improve outcomes of paclitaxel therapy for human epidermal growth factor receptor-2 (HER-2)–positive patients, and was therefore incorporated. Because inhibition of HER-family signaling had potential efficacy even without HER-2 overexpression, we randomly assigned for trastuzumab in this population. Patients and Methods: Patients were randomly assigned to paclitaxel 175 mg/m 2 every 3 weeks or 80 mg/m 2 weekly. After the first 171 patients, all HER-2–positive patients received trastuzumab; HER-2 nonoverexpressors were randomly assigned for trastuzumab, in addition to paclitaxel schedule. A total of 577 patients were treated on 9840. An additional 158 patients were included in analyses, for combined sample of 735. The primary end point was response rate (RR); secondary end points were time to progression (TTP), overall survival, and toxicity. Primary comparisons were between weekly versus every-3-weeks paclitaxel, and trastuzumab versus no trastuzumab in HER-2 nonoverexpressors. Results: In the combined sample, weekly paclitaxel was superior to every-3-weeks administration: RR (42% v 29%, unadjusted odds ratio [OR] = 1.75; P = .0004), TTP (median, 9 v 5 months; adjusted HR = 1.43; P < .0001), and survival (median, 24 v 12 months; adjusted HR = 1.28; P = .0092). For HER-2 nonoverexpressors, trastuzumab did not improve efficacy. Grade 3 neuropathy was more common with weekly dosing (24% v 12%; P = .0003). Conclusion: Weekly paclitaxel is more effective than every-3-weeks administration for MBC. Trastuzumab did not improve efficacy for HER-2 nonoverexpressors. Neurotoxicity is a treatment-limiting toxicity for weekly paclitaxel.
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Self-citationTrastuzumab plus Adjuvant Chemotherapy for Operable HER2-Positive Breast Cancer
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Weekly vs. Every-3-Week Paclitaxel and Carboplatin for Ovarian Cancer
Chan, J. K., Brady, M. F., Penson, R. T., Huang, H., Birrer, M. J., Walker, J. L., DiSilvestro, P. A., Rubin, S. C., Martin, L. P., Davidson, S. A., et al. (2016) · New England Journal of Medicine · doi:10.1056/nejmoa1505067 · Cited by 367
Overview of neuropathy associated with taxanes for the treatment of metastatic breast cancer
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Fujiwara, Y., Mukai, H., Saeki, T., Ro, J., Lin, Y.-C., Nagai, S. E., Lee, K. S., Watanabe, J., Ohtani, S., Kim, S. B., et al. (2019) · British Journal of Cancer · doi:10.1038/s41416-019-0391-z · Cited by 147
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Metadata
- Authors
- Seidman, A. D., Berry, D., Cirrincione, C., Harris, L., Muss, H., Marcom, P. K., Gipson, G., Burstein, H., Lake, D., Shapiro, C. L., Ungaro, P., Norton, L., Winer, E., & Hudis, C.
- Venue
- Journal of Clinical Oncology
- Published
- 2008-04-01
- Volume
- 26
- Issue
- 10
- Pages
- 1642-1649
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W2136791645
- Cited by
- 594
- References
- 22
- FWCI
- 31.11
- Type
- journal article
- Language
- en
- Open access
- bronze
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- Seidman, A. D., Berry, D., Cirrincione, C., Harris, L., Muss, H., Marcom, P. K., Gipson, G., Burstein, H., Lake, D., Shapiro, C. L., Ungaro, P., Norton, L., Winer, E., & Hudis, C. (2008). Randomized Phase III Trial of Weekly Compared With Every-3-Weeks Paclitaxel for Metastatic Breast Cancer, With Trastuzumab for all HER-2 Overexpressors and Random Assignment to Trastuzumab or Not in HER-2 Nonoverexpressors: Final Results of Cancer and Leukemia Group B Protocol 9840. Journal of Clinical Oncology. https://doi.org/10.1200/jco.2007.11.6699
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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
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