Carcinoma cervix is the fourth most commonly diagnosed cancer and the fourth leading cause of cancer death in females worldwide. In India, it is the second most common malignancy to affect females. This is a prospective comparison of weekly paclitaxel to weekly cisplatin as concurrent chemotherapy with standard radiotherapy for locally advanced carcinoma cervix.
Between Jan 2011 and March 2012, 50 women with histologically proved squamous cell carcinoma cervix (FIGO stage IIA-IIIB), Eastern Cooperative Oncology Group (ECOG) performance status 0-2, who met inclusion criteria were enrolled into this prospective study and randomized to receive on a weekly basis either 40 mg/m2 cisplatin (group I; 25 patients) or 50 mg/m2 paclitaxel (group II; 25 patients) concurrently with radiotherapy. Total dose to point A was 82.81 Gy (50 Gy by conventional external beam radiotherapy and 32.31 Gy of equivalent dose 2 Gy by high dose rate intracavitary brachytherapy). Median follow-up time was 46 months. The primary endpoint of the study was treatment response. Chi-square test was used for comparative analysis. Statistical significance was defined as P value < 0.05. Data were analyzed using a SPSS program version 10.0. Treatment related toxicity, progression free survival and overall survival were assessed as secondary endpoint.
Patient and tumor characteristics were similar in both groups. The mean number of chemotherapy cycles was also comparable with 87% and 80% of patients receiving at least 4 doses in groups I and II, respectively. Seven patients (28%) of group I and 8 patients (32%) of group II developed tumor recurrence. The Median survival time was not reached for Group I and 53 months for group II. The proportion of patients surviving at 2 and 5 years was 78% and 54% for group I and 73% and 43% for group II respectively.
This small prospective study shows that concurrent chemoradiation for locally advanced carcinoma cervix using weekly paclitaxel was not superior to concurrent cisplatin and it was associated with more severe gastrointestinal and haematological toxicities but less nausea, vomiting and nephrotoxicity as compared to weekly cisplatin.
Clinical trial identification
All authors have declared no conflicts of interest.