Weekly cisplatin or gemcitabine concomitant with radiation in the management of locally advanced carcinoma cervix: results from an observational study

Abstract

Objective: The use of non-platinum drugs in concurrent chemoradiation in carcinoma cervix has not been well explored and hence a two arm study was planned to compare the outcome of concomitant cisplatin or gemcitabine in locally advanced carcinoma cervix. Methods: Thirty six patients were evaluated in this study for response rates and complications. These patients were divided into two arms, sixteen patients in the cisplatin arm and twenty patients in the gemcitabine arm. Cisplatin and gemcitabine were given as i.v. infusion at doses of 40 mg/m 2 and 150 mg/m 2 respectively for five weeks concomitant with radiotherapy. All patients had received pelvic radiotherapy to a dose of 50 Gy/25 fraction/5 weeks by four field box technique followed by high-dose-rate brachytherapy (3 sessions, each of 7.5 Gy to point A). Results: Median follow up was of 10.4 months (range, 3 to 36 months) and 10.9 months (range, 2 to 49 months) in the cisplatin and gemcitabine arms, respectively. At first follow up, 68.8% in the cisplatin arm and 70% in the gemcitabine arm had achieved complete response (p=0.93). Similar response rates were noted in different stages in both arms. None of the patients except one developed grade 4 toxicity. Similar toxicity profiles were observed in both arms. Local disease control, distant disease free survival and overall survival was 68.8% vs. 70%, 93.8% vs. 85%, 68.8% vs. 60% in the cisplatin and gemcitabine arms, respectively. Conclusion: Weekly gemcitabine had similar disease control and tolerable toxicity profile with cisplatin. Gemcitabine may be used as an alternative to cisplatin in patients with compromised renal function.

Feasibility of Weekly Cisplatin Versus Gemcitabine Concomitant with Radiation in The Management of Locally Advanced Carcinoma Cervix

“…Probably low economic condition resulting in poor general condition of cervical cancer patients in our country is the cause of high incidence of anemia and other haematological toxicities met in the present study. Grade 2 dermatitis was more in cisplatin group 16% vs. 12% in gemcitabine group and is similar to the study done by Arun k et al (15) . Grade 3 toxicity was not seen in our study as evident in study by Bhatt et al (9) .…”

“…Grade 1 thrombocytopenia was seen in 8% and 4% patients in group A and group B respectively in our study. This was comparable with the study by Arun K et al (15) in which grade 1 thrombocytopenia was 2/20 vs 0/16 in gemcitabine and cisplatine arm respectively. Probably low economic condition resulting in poor general condition of cervical cancer patients in our country is the cause of high incidence of anemia and other haematological toxicities met in the present study.…”

“…The study had grade 2/3 leucopenia of 18% and 15.6% in gemcitabine and cisplatin arm respectively. In the study, by Arun et al (15) grade 3 lucopenia was observed in one patient receiving gemcitabine. No grade 3 leucopenia was found in cisplatin arm.…”

Time for global efforts with clinical trials for advanced cervical cancer patients

“…Phase I study with docetaxel as a radiation sensitizer has been reported. 7 Verma et al 4 reported the results from observational study between weekly cisplatin and weekly gemcitabin during radiation therapy with equal disease control rate and tolerable toxicity profile. In his review, results from combined cisplatin and gemcitabin with radiation were thoroughly reviewed in discussion.…”

“…In this issue of Journal of Gynecology Oncology, there are 3 articles dealing with cervical cancer either with locally advanced tumor or with metastatic nodes at paraaortic region found at the time of operation. [3][4][5] Radiation has been the primary treatment modality for locally advanced cervical cancer (FIGO stage IB2-IVA). Weekly cisplatin is a standard one as a concurrent chemo-radiotherapy with improved local control and survival.…”