An open label randomized phase 2, study of weekly vs 3 weekly paclitaxel and carboplatin in stage IVB or recurrent carcinoma cervix

Aim/Background

To compare weekly and three weekly schedules of paclitaxel and carboplatin in stage IVB or recurrent or persistent carcinoma cervix.

Methods

This was a prospective, randomized phase II pilot study. Consecutive patients of metastatic, recurrent or persistent carcinoma cervix were enrolled in the study after taking informed consent and institutional ethics committee aproval. (IESC/T-352/38/2013RT23/1/11/2013). Eligible patients were: Histologically proven case of squamous or adeno or adenosquamous carcinoma, ECOG performance status (PS0) 0,1or 2, Measurable disease by CT scan. Patients with ECOG PS 3 or 4, impaired renal /liver functions, prior chemotherapy for metastatic disease, HIV positive, CNS metastasis, bilateral hydronephrosis were excluded. Patients were randomized by a random table into two arms. Arm 1 received paclitaxel 60 mg/ m², carboplatin AUC 2 every weekly. Arm 2 received paclitaxel 175 mg/ m², carboplatin AUC 6 every three weekly. Patients were followed up and responses were assessed after three cycles and every three monthly thereafter

Results

Between September 2013 and January 2014, 52 patients were enrolled; four were considered ineligible, one declined chemotherapy, and three patients withdrew after 1^st cycle of chemotherapy. 23 patients in each arm were eligible for assessment. Median age in both groups was 50 years. Three weekly chemotherapy was associated with better response rate (43% vs 13%), longer progression free survival (PFS) 7.6 (95% CI, 5.9-9.5) months vs 4.7 (95% CI 3.6-5.7) months, (p = 0.03). However, 1 year PFS was comparable (12.4% in three weekly vs 13% in weekly arm, p = 0.8). OS was higher in 3 weekly arm, 11.9 vs 7 months, HR 0.4, 95% CI 0.1- 0.9, p = 0.04. More patients (73% vs 48%) completed therapy in 3 weekly arm. More patients (86% vs 65%) required PRBC transfusion in weekly arm.

Conclusions

Three weekly paclitaxel and carboplatin can be used in the treatment of recurrent and metastatic cervical cancer. Three weekly schedule was associated with better response rates, improved PFS and OS compared to weekly schedule. Major toxicity associated with both regimens were myelosuppression. Anemia was higher in weekly arm.

Clinical trial identification

NCT02492503

Disclosure

All authors have declared no conflicts of interest.