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Cisplatin plus gemcitabine improves outcomes in metastatic triple-negative breast cancer
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Cisplatin plus gemcitabine demonstrated superior PFS outcomes compared with paclitaxel plus gemcitabine for women with metastatic triple-negative breast cancer, according to results of a randomized phase 3 study.
“Despite general improvements in the management of breast cancer, triple-negative breast cancer represents a continuing challenge because, when compared with other subtypes, it is associated with a higher frequency of recurrence, shorter DFS and poor OS, despite similar therapeutic approaches to other breast cancers,” Xi-Chun Hu, MD, of the department of medical oncology at the Fudan University Shanghai Medical College, and colleagues wrote. “The median distant disease-free interval for relapsed triple-negative breast cancer is about 1 to 2 years and the median survival for metastatic triple-negative breast cancer is about 1 year.”
Hu and colleagues evaluated data from 236 patients (median age, 47 years) from 12 institutions or hospitals within the Chinese Breast Cancer Study Group. Patients had not undergone previous chemotherapy for metastatic disease and they had an ECOG performance status of 0 to 1.
Researchers randomly assigned patients 1:1 to a chemotherapy regimen of 1,250 mg/m2 gemcitabine on days 1 and 8 plus 75 mg/m2 cisplatin or 175 mg/m2 paclitaxel on day 1 for eight 3-week cycles.
PFS served as the primary endpoint. Secondary endpoints included OS, objective response and safety.
Median follow-up was 16.3 months in the cisplatin arm and 15.9 months in the paclitaxel arm.
Median PFS was 7.73 months (95% CI, 6.16-9.3) in the cisplatin arm and 6.47 months (95% CI, 5.76-7.18) in the paclitaxel arm. Researchers calculated a 0.69 HR (95% CI, 0.52-0.91) for PFS, which indicated that cisplatin plus gemcitabine was noninferior (P ˂ .0001) and superior (P = .009) to paclitaxel plus gemcitabine.
The ORR was significantly higher in the cisplatin arm in both the modified intention-to-treat population (64% vs. 49%; P = .018) and the per-protocol population (68% vs. 54%; P = .045).
OS data were immature at the time of publication, although death from any cause occurred in a comparable number of patients the cisplatin (n = 48) and paclitaxel (n = 49) arms.
All 236 patients experienced at least one adverse event. Patients in the cisplatin arm experienced significantly higher rates of grades 3 to 4 nausea (7% vs. ˂ 1%), vomiting (11% vs. ˂ 1%), anemia (33% vs. 5%) and thrombocytopenia (32% vs. 3%); however, patients in the paclitaxel arm experienced significantly higher rates of musculoskeletal pain (8% vs. 0%).
Four patients in the cisplatin group and three patients in the paclitaxel group experienced serious drug-related adverse events; however, no treatment-related deaths occurred.
The researchers acknowledged several limitations to these findings, including that the College of American Pathologists modified the hormone receptor cutoff value within their guidelines after the study closure, which could have led researchers to use a different definition of triple-negative breast cancer. Further, several studies have suggested since the current study’s design was completed in 2010 that weekly paclitaxel is more effective than a 3-week schedule.
“Compared with the more established paclitaxel plus gemcitabine regimen, our cisplatin plus gemcitabine regimen could be an alternative or even the preferred first-line chemotherapy strategy for patients with metastatic triple-negative breast cancer,” Hu and colleagues concluded. “Future work could include a validation of our cisplatin plus gemcitabine regimen in non-Asian patients and the identification of predictive markers for treatment with platinum-based regimens for patients with metastatic triple-negative breast cancer.” – by Cameron Kelsall
Disclosure: Eli Lilly provided gemcitabine for the study. The researchers report no relevant financial disclosures.
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