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Carboplatin noninferior to cisplatin for metastatic, recurrent cervical cancer
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Carboplatin-based chemotherapy should be a standard treatment option for metastatic or recurrent cervical cancer, according to findings from a randomized phase 3 trial.
Palliative chemotherapy is an option for women with metastatic or recurrent cervical cancer. Cisplatin has been the active agent most often used in that setting.
Combining cisplatin with paclitaxel has vastly improved response rate and PFS while maintaining a tolerable level of toxicity, according to study background. However, cisplatin requires hydration, which means a hospital stay is required during each cycle of administration.
Carboplatin does not require hydration, can be administered on an outpatient basis and is less toxic than cisplatin. It has not shown an efficacy that is equal to or better than cisplatin, although they had never been compared in a phase 3 trial.
Ryo Kitagawa MD, of the department of gynecology and obstetrics at NTT Medical Center in Tokyo, and colleagues conducted a phase 3 trial to compare carboplatin plus paclitaxel with cisplatin plus paclitaxel.
The multicenter, open-label trial was designed to evaluate efficacy, safety and quality of life associated with carboplatin-based chemotherapy in women with metastatic or recurrent cervical cancer.
The analysis included 253 women (age range, 20 to 75 years) with histologically confirmed stage IVB or first or second recurrence of cervical cancer not amenable to curative surgery or radiotherapy. The patients, enrolled between February 2006 and November 2009, had undergone a maximum of one prior platinum-based chemotherapy or taxane-containing chemotherapy regimen.
The investigators randomly assigned 127 women to treatment with paclitaxel 135 mg/m² intravenously over a span of 24 hours on day 1, followed by cisplatin 50 mg/m² intravenously on day 2.
The other 126 women received paclitaxel 175 mg/m² intravenously over 3 hours on day 1, immediately followed by a 1-hour IV infusion of carboplatin at area under the curve of 5 mg/mL per minute.
OS served as the primary endpoint. Secondary endpoints included PFS, response rate, quality of life and adverse events.
Median follow-up was 17.6 months. During that time, 204 OS events were observed.
Median OS was 18.3 months (95% CI, 16.1-22.9) in the cisplatin group and 17.5 months (95% CI, 14.2-20.3) in the carboplatin group, equating to an HR of 0.994 (multiplicity-adjusted 90% CI, 0.78-1.25).
Among patients who had not received prior cisplatin-based chemotherapy, median OS was 13 months (95% CI, 10-20.4) among those assigned carboplatin and 23.2 months (95% CI, 17.4-27.4) among those assigned cisplatin, translating to an HR of 1.571 (95% CI, 1.06-2.32).
Median PFS was 6.9 months (95% CI, 5.7-7.9) in the cisplatin arm and 6.2 months (95% CI, 5.5-7.2) in the carboplatin arm (HR = 1.041; 95% CI, 0.8-1.35).
Researchers reported one treatment-related death in the carboplatin arm due to interstitial pneumonitis. The percentage of patients who discontinued treatment due to adverse events were similar (carboplatin, 9.5%; cisplatin, 11.8%).
Kitagawa and colleagues also reported significantly longer proportion of nonhospitalization periods in the carboplatin group (P < .001).
“[This] is the first trial demonstrating significant noninferiority of carboplatin-based chemotherapy in terms of OS and clinical benefits for cervical cancer,” Kitagawa and colleagues wrote. “[Carboplatin-based chemotherapy] should be a standard treatment option for metastatic cervical cancer. However, cisplatin is still the key drug for patients who have not received prior cisplatin-based treatment, such as those with primary stage IVB cervical cancer.” – by Anthony SanFilippo
Disclosure: The researchers report honoraria from Ono Pharmaceutical and Chugai Pharmaceutical.
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