Sabera Khatun

Safety and Immunogenicity Profile of Human Papillomavirus-16/18 AS04 Adjuvant Cervical Cancer Vaccine: A Randomized Controlled Trial in Healthy Adolescent Girls of Bangladesh

Aim Bangladesh has the highest level of incidence and mortality rates due to cervical cancer among women. The prevalence of cervical cancer in Bangladeshi women is 25–30/100 000. Human papillomavirus is an important cause of cervical cancer. The study was conducted to assess the immunogenicity and safety profile of human papillomavirus-16/18 AS04-adjuvanted cervical cancer vaccines in healthy Bangladeshi girls aged 9–13 years. Procedure This was a randomized (3:1) controlled trial with two parallel groups, the vaccine and control groups, that included 67 participants in Bangladesh. Subjects were given GlaxoSmithKline human papillomavirus-16/18 AS04-adjuvanted cervical cancer vaccine (and controls no vaccine) at the first day of vaccination (Day 0), at 1- and 6-month schedule and followed up until 7 months. Blood samples were taken for human papillomavirus antibody at enrollment and 1 month post-schedule at Month 7 from both subjects and controls. Safety data were gathered throughout the study period. Results Fifty subjects received vaccine at Day 0, 1 month and 6 months. All subjects were initially sero-negative in the vaccine group, and developed sero-conversion for human papillomavirus-16 and -18 antibodies except for one at Month 7. Seventeen controls did not receive vaccine. Clients were followed up for serious medically important events and blood samples were taken for human papillomavirus antibody detection at Day 0 and Month 7. Sero-conversion was found in 97.5% of subjects and no sero-conversion was found in the controls. Bivalent human papillomavirus vaccine was generally well tolerated, with no vaccine-related serious adverse experiences. Conclusions The human papillomavirus-16/18 AS04-adjuvanted vaccine was generally well tolerated and highly immunogenic when administered to young adolescent females and could be a promising tool for the prevention and control of cervical cancer in Bangladesh.

Role of Neoadjuvant Chemotherapy in Treatment of Cervical Cancer: A Case Series of Thirty-Eight Patients Treated at Bangabandhu Sheikh Mujib Medical University in Dhaka, Bangladesh

Background: Cervical cancer is the second most common malignancy of women in Bangladesh. Surgery is the mainstay of treatment of patients with early invasive cancer confined to cervix. While the five-year survival rate after surgery for stage IB1 disease exceeds 90%, it is only 60% - 70% for stage IB2 and IIA2 (tumor size > 4 cm). To improve the outcome of treatment, two to three cycles of Neoadjuvant Chemotherapy (NACT) has been evaluated as a treatment strategy in stage IB2 and IIA2 diseases. Objectives: This study aimed to evaluate the role of neoadjuvant chemotherapy (NACT) followed by Radical Surgery (RS) among the patients with early bulky cervical cancer (Stage IB2 & IIA2) to reduce the tumor size to achieve radical resectibility. Methods: This study was carried out at the Gynaecological Oncology Division of the Department of Obstetrics and Gynecology at Bangabandhu Sheikh Mujib Medical University (BSMMU) during the period July 2015 to December 2015. Thirty-eight patients with early bulky cervical cancer without any prior medical or surgical treatment received NACT using intravenous paclitaxel 175 mg/m2 and cisplatin 75 mg/m2 followed by radical surgery. The primary outcome measure assessed the response to NACT to reduce the size of the tumor. Secondary outcome measures assessed the resectibility of tumor and compared the preoperative clinical stage to the postoperative pathological stage. This study also assessed the relationship of intraoperative and postoperative complications including the adverse effects of postoperative radiotherapy and chemoradiotherapy. Results: Clinical response to NACT was 94.7% (84.2% complete response + 10.5% partial response). Progressive disease was found in two cases (5.3%). Duration of surgery was less than 2 hours in 81.6% cases and greater than 3 hours in 13.2% cases only. All women lived 5 to 10 hours away from Dhaka and could not return for in person follow-up. It was possible to get telephone follow-up on twenty-four women (63%). Seven (29%) had died from their cancers within one year of their surgery. Seventeen women were alive and disease free two years after completeion of their treatment. Conclusion: NACT is a feasible approach for improving the resectability of early stage bulky cervical cancer at BSMMU.