External Beam Therapy in a Four-Field Box Technique with Paclitaxel versus a Two-Field Technique with Cisplatin in Locally Advanced Carcinoma Cervix: A Phase II Monocentric Trial
Introduction. External beam pelvic radiotherapy with cisplatin and brachytherapy is the standard of care for patients with advanced cervical malignancy. This study was aimed at evaluating the toxicity of a two-field radiotherapy with cisplatin and brachytherapy compared to a four-field box technique with paclitaxel and brachytherapy for stages IIB/IIIB cervical cancer. The differences in response to the overall treatment were also examined. Methods. 35 patients were enrolled in this phase II prospective randomized trial conducted from February 2006 to February 2007. In arm I, up to 40？Gy in 20 fractions followed by 10？Gy in 5 fractions in split field with cisplatin 40？mg/M2 and, in arm II, 50？Gy in 25 fractions with paclitaxel 50？mg/M2 were given. Results. Toxicity in genitourinary, lower gastrointestinal, and hematological tissues was significantly higher in arm I. The duration of concurrent chemoradiotherapy in either arm was similar. The overall treatment time was less in arm II. No statistically significant difference in the objective response was observed between arms. Conclusion. Two-field radiotherapy with cisplatin is a tolerable regime but more toxic than four-field box radiotherapy with paclitaxel. The major setbacks are that a radiotherapy technique as well as chemotherapy is different; hence, toxicity and outcome of treatment should be viewed as a collective response of the whole treatment regimen and the small sample size. 1. Introduction The commonest gynecological cancer before the age of 50 is carcinoma cervix. The incidence is high in developing and underdeveloped countries. Women belonging to low socioeconomic status show higher incidence [1]. Though there is no population-based cancer registry in Nepal, incidence of the age-standardized incidence rate and mortality rate is estimated to be 26.4 per 100000 women and 14.1 per 100000 women, respectively. Similarly, the incidence of cervical cancer per 100000 women in India, Bangladesh, and Sri Lanka is estimated to be 30.7, 27.6, and 17.7, respectively [2]. Poor personal hygiene, poor nutritional status, multiple sexual partners, first coitus in young age, early child birth, promiscuity of the spouse, human papilloma virus infection, sexually transmitted diseases, and immunocompromised states are cited as main risk factors [3, 4]. Though there is tremendous breakthrough in cancer research and changes in clinical practice, the nature of disease still remains the same. Early carcinoma of the uterine cervix can be effectively managed either by surgery or by radiotherapy; the results are
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