Phase II randomized trial of cisplatin chemotherapy regimens in the treatment of recurrent or metastatic squamous cell cancer of the cervix: a Southwest Oncology Group Study.

Abstract

Cisplatin has proven to be the most active single agent in the treatment of metastatic and recurrent squamous cell cancer of the cervix. In a previous southwest Oncology Group (SWOG) pilot study, the addition of cisplatin to a mitomycin-C, vincristine, and bleomycin (MVB) regimen resulted in a relatively high percentage of durable complete responses. To gain more experience with cisplatin-based chemotherapy regimens, the SWOG initiated a phase II randomized trial of cisplatin, mitomycin-C plus cisplatin (MC), and MVB plus cisplatin (MVBC) in 119 patients with advanced squamous cell cancer of the cervix and no prior chemotherapy exposure. Because of slow patient accrual early in the trial, the cisplatin arm was discontinued. Five patients were declared ineligible according to protocol criteria. The three treatment groups were relatively well matched for age, prior radiation exposure, and sites of measurable disease. The overall objective response rates for cisplatin, MC, and MVBC treated patients were 33%, 25%, and 22%, respectively. Median response durations were greater than 6 months. Median survival durations associated with cisplatin, MC, and MVBC treatment were 17.0, 7.0, and 6.9 months, respectively. There were no drug-related deaths. Severe or life-threatening leukopenia and thrombocytopenia were observed in 18% to 24% of patients treated with MVBC and MC, but in none of those receiving cisplatin alone. We conclude that the low response rates and short durations of both response and survival observed in patients randomized to the two chemotherapy combinations suggest that only enhanced toxicity was gained through the addition of mitomycin-C or MVB to cisplatin in patients with advanced cervix cancer.

Combination therapy with irinotecan and cisplatin as neoadjuvant chemotherapy in locally advanced cervical cancer

“…In addition to cisplatin, bleomycin, 5-fluorouracil, mitomycin C, ifosfamide, vincristine, adriamycin and CPT-11 are also active against uterine cervical cancer (Thigpen et al, 1981(Thigpen et al, , 1995Alberts et al, 1987;Lahousen et al, 1987;Takeuchi et al, 1991;Omura et al, 1992;Verschraegen et al, 1997;Irvin et al, 1998). In a previous phase II study of the effect of CPT-11 alone on recurrent cervical cancer in Japan, CPT-11 was given at a dose of 100 mg m Ð2 four times with 1-week intervals and at a dose of 150 mg m Ð2 three times with 2-week intervals (Takeuchi et al, 1991).…”

“…Studies on the use of cisplatin have shown that squamous cell carcinoma of the uterine cervix is sensitive to chemotherapy (Thigpen et al, 1981;Alberts et al, 1987). Various cisplatin-based regimens have been associated with high responses in patients with advanced and recurrent cervical cancers (Lahousen et al, 1987;Omura et al, 1992;Thigpen et al, 1995).…”

Gynecologic oncology group trials of chemotherapy for metastatic and recurrent cervical cancer

“…Investigators within the trialist group designed two phase II trials in parallel, without randomization or interdrug comparisons, and observed strikingly different toxicity profiles from that of the parent drug [11,12]. To gain experience with cisplatin-based combined regimens, the Southwest Oncology Group (SWOG) initiated a phase II randomized trial of cisplatin versus mitomycin-C plus cisplatin versus mitomycin-C (MC), vincristine, bleomycin plus cisplatin (MVBC) in 114 evaluable patients with advanced squamous cell carcinoma of the cervix and no prior chemotherapy exposure [13]. The overall objective response rates for cisplatin, MC, and MVBC were 33%, 25%, and 22%, respectively, and the median survival durations were 17.0 months, 7.0 months, and 6.9 months, respectively.…”

Development and Clinical Evaluation of Dendritic Cell Vaccines for HPV Related Cervical Cancer - a Feasibility Study

“…Reports of an excellent complete response in metastatic cervical cancer are rare. A review on chemotherapy for metastatic and/or recurrent cervical cancer (Scatchard et al, 2012) found that in two randomized control studies, the median survival of patients after single agent cis-platin chemotherapy for metastatic disease was 17 (Alberts et al, 1987) and 13 (Cadron et al, 2005) months respectively. It is therefore interesting to speculate as to whether the DC vaccine had a contributory role in this patient achieving a sustained disease free status.…”