Ajeet Kumar Gandhi

Early Clinical Outcomes and Toxicity of Intensity Modulated Versus Conventional Pelvic Radiation Therapy for Locally Advanced Cervix Carcinoma: A Prospective Randomized Study

PURPOSE To evaluate the toxicity and clinical outcome in patients with locally advanced cervical cancer (LACC) treated with whole pelvic conventional radiation therapy (WP-CRT) versus intensity modulated radiation therapy (WP-IMRT). METHODS AND MATERIALS Between January 2010 and January 2012, 44 patients with International Federation of Gynecology and Obstetrics (FIGO 2009) stage IIB-IIIB squamous cell carcinoma of the cervix were randomized to receive 50.4 Gy in 28 fractions delivered via either WP-CRT or WP-IMRT with concurrent weekly cisplatin 40 mg/m(2). Acute toxicity was graded according to the Common Terminology Criteria for Adverse Events, version 3.0, and late toxicity was graded according to the Radiation Therapy Oncology Group system. The primary and secondary endpoints were acute gastrointestinal toxicity and disease-free survival, respectively. RESULTS Of 44 patients, 22 patients received WP-CRT and 22 received WP-IMRT. In the WP-CRT arm, 13 patients had stage IIB disease and 9 had stage IIIB disease; in the IMRT arm, 12 patients had stage IIB disease and 10 had stage IIIB disease. The median follow-up time in the WP-CRT arm was 21.7 months (range, 10.7-37.4 months), and in the WP-IMRT arm it was 21.6 months (range, 7.7-34.4 months). At 27 months, disease-free survival was 79.4% in the WP-CRT group versus 60% in the WP-IMRT group (P=.651), and overall survival was 76% in the WP-CRT group versus 85.7% in the WP-IMRT group (P=.645). Patients in the WP-IMRT arm experienced significantly fewer grade ≥2 acute gastrointestinal toxicities (31.8% vs 63.6%, P=.034) and grade ≥3 gastrointestinal toxicities (4.5% vs 27.3%, P=.047) than did patients receiving WP-CRT and had less chronic gastrointestinal toxicity (13.6% vs 50%, P=.011). CONCLUSION WP-IMRT is associated with significantly less toxicity compared with WP-CRT and has a comparable clinical outcome. Further studies with larger sample sizes and longer follow-up times are warranted to justify its use in routine clinical practice.

High-dose-rate interstitial brachytherapy for T1-T2-stage penile carcinoma: short-term results.

PURPOSE Interstitial brachytherapy (IBT) is a preferred treatment option over partial penectomy in selected patients with T1-T2-stage penile carcinoma because of its organ preservation ability. Literature is mostly based on the use of low-dose-rate IBT, and experience with high-dose-rate (HDR) IBT is extremely limited. We studied the role of HDR-IBT alone in patients with T1-T2-stage penile carcinoma. METHODS AND MATERIALS Between April 2010 and July 2013, 14 patients with T1-T2-stage penile carcinoma were treated with HDR-IBT at our center. Size of the primary lesion ranged from 1.5 to 4.0cm. A two-to-four-plane free-hand implant was performed using plastic catheters. The prescribed dose of HDR-IBT was 42-51Gy in 14-17 fractions using twice-a-day fractionation schedule. Patients were followed up regularly for assessment of local control, survival, toxicity, and sexual function. RESULTS At a median followup of 22 months, 2 patients developed recurrent disease at locoregional site. The 3-year overall survival was 83% with penis preservation rate of 93%. All patients developed acute Grade III skin toxicity that healed during 6-8-weeks time. Urethral stenosis and soft tissue necrosis was not seen in any of the patients. A total of 4 patients experienced mild asymptomatic fibrosis in the implanted area. Around 10 patients had satisfactory sexual function status at the last followup visit. CONCLUSIONS Although it was a small sample size, our results have demonstrated excellent local control rate and acceptable toxicity with HDR-IBT in patients with T1-T2-stage penile carcinoma.

National cancer control and registration program in India.

Indian Journal of Medical and Paediatric Oncology | Oct-Dec 2014 | Vol 35 | Issue 4 Cancer has emerged as a major public health concern in India. 12.5 lakh new cases are diagnosed every year and around 28 lakh cases of cancers are prevalent at any given point of time. It also claims lives of about 6.8 lakh patients per year.[1] According to the World Health Organization (WHO), death from cancer cases in India is projected to rise to 13.1 million by the year 2030. The burden of cancer is expected to further increase due to increase in life expectancy, demographic transitions and the effects of tobacco and other risk factors. As per latest data of India from GLOBOCAN 2012,[1] top three cancers in female are breast, cervix uteri and colo-rectum and in male are oral cavity, lung and stomach. Most cancer cases in India are associated with tobacco use, infections, and other avoidable causes. Social factors, especially inequalities, are major determinants of India’s cancer burden,[2] with poorer people more likely to die from cancer before the age of 70 years than those who are more affluent. National Cancer Registry Programme (NCRP) data of Indian Council of Medical Research (ICMR)[3] suggest a wide demographic variation in incidence of cancer. While Aizwal district has an age-adjusted incidence rate (AARs) of 273.4, the rural registry of Barshi in Maharashtra has an AAR of 51.8. These data reflect the impact of environmental and cultural factors on the incidence of cancer. In urban registries like Delhi, Mumbai and Thiruvananthapuram, breast cancer is the most common cancer in women[4] and in registries such as Barshi, Aizwal and Guwahati, cervical cancer is most common in women. Cancer of the stomach and liver are among the most common malignancies in Mizoram and carcinoma of the gall bladder figures among the top five cancers in some registries such as Delhi and Dibrugarh.

High-dose-rate interstitial brachytherapy for liver metastases: first study from India

Purpose To study the safety and efficacy of high-dose-rate interstitial brachytherapy (HDRIBT) in patients with liver metastases (LM). Material and methods Between 2009 and 2011, 10 patients with 12 metastatic lesions in the liver were enrolled in this prospective trial. All patients had either refused surgery or found ineligible for surgery due to various factors. Under CT guidance, 16 gauze blind end stainless steel or rigid plastic brachytherapy needle was inserted in the center of lesion through the percutaneous route. Generally, a single interstitial brachytherapy (IBT) needle for lesions up to 3 cm and multiple needles for lesions more than 3 cm in diameter were inserted. Treatment was delivered with a single high-dose-rate (HDR) dose of 20 Gy prescribed to the target. The needles were removed immediately after the treatment. The endpoints of study were acute complications and local control of the disease. Results The median size of the lesion was 3.8 cm (2.7-7.0 cm). The average time for the entire IBT procedure was 65 minutes (50-105 minutes). Median follow up was 9 months (3-17 months). None of the patients had fatal complications. Minor complications like pain, nausea/vomiting, and asymptomatic pleural effusion were observed in 3, 2 and 1 patients, respectively. Local control rate at 12 months was 75%. The 1-year local progression free survival (LPFS) was 33%. Conclusion Although limited by small sample size, the results of our first study from India suggest that HDRIBT is a safe and effective non surgical option for LM.

Postoperative treatment of glioblastoma multiforme with radiation therapy plus concomitant and adjuvant temozolomide : A mono-institutional experience of 215 patients.

OBJECTIVE To study the clinical results and prognostic factors of patients with glioblastoma multiforme (GBM) treated by postoperative radiation therapy (PORT) and concomitant temozolomide followed by adjuvant temozolomide. METHODS From 2005 to 2008, 215 patients (median age 48 years) with GBM were treated with PORT plus temozolomide chemotherapy. Radiation therapy (RT) was employed with a dose of 60 Gy in 30 fractions over 6 weeks by conventional fractionation with concomitant temozolomide (75 mg/m(2)/day). Adjuvant therapy consisted of 6 cycles of temozolomide (150 mg/m(2) for 5 days, 28 days cycle). The primary end point of the study was overall survival (OS), and the secondary end points were progression free survival (PFS) and toxicity. OS was determined with respect to different variables to study the prognostic significance. RESULTS Median follow up was 11 months (range 2-50 months). Median OS and PFS were 13 months and 11 months respectively. The 1-year and 2-year OS was 44% and 18% respectively. There was no statistical significant impact of age, sex, KP score, anatomical location and extent of surgery. Presentation without seizures (on univariate analysis) and 6 cycles of adjuvant temozolomide therapy (on univariate as well as multivariate analysis) were found significant prognostic factors. Sixteen patients developed grade III-IV neutropenia/thrombocytopenia during the course of RT. CONCLUSION Our results authenticate the role of concomitant and adjuvant temozolomide chemotherapy in combination with PORT for the management of GBM patients. We strongly recommend complete 6 cycle of adjuvant temozolomide since it significantly improved the survival in our study.

Clinical outcome of patients with uterine sarcomas

PURPOSE The aim of our retrospective analysis was to study and report the clinical outcome of patients with uterine sarcoma (US) treated at our center; and to share our experience with literature. MATERIALS AND METHODS We retrieved the information regarding the patients demography, clinico-pathological details, treatment given, survival, and complications of all the US patients treated at our center between the years 2000-2008. The three-year overall survival (OS) was determined with respect to various prognostic factors like age, stage of disease, histopathological type, adjuvant RT etc. RESULTS A total of 50 case records were retrieved for this retrospective analysis. Age ranged from 24 to 75 years with a median of 50 years. Carcinosarcoma was the commonest histopathological type (23/50 patients). FIGO stage distribution was: stage I, 27; stage II, 7; stage III, 12; stage IV, 2; and unknown stage, two patients. Forty-eight patients underwent surgery; 31 received postoperative radiation therapy (PORT) and 16 received chemotherapy therapy. Median follow-up period was 34 months (range 2-69 months). The three-year OS for the entire group of patients was 42%. Stage of the disease, histopathological type, and use of PORT were found significant prognostic factors for survival. CONCLUSION Although limited by small sample size and retrospective nature, ours is the only study on US being reported from India. Our results have demonstrated FIGO stage of the disease, histopathology and use of PORT to be the significant prognostic factor for survival. Use of chemotherapy in future trials is warranted.

Symptom burden and quality of life in advanced head and neck cancer patients: AIIMS study of 100 patients

Aim: Head and neck cancers (HNCa) are the most common cancers among males in India and 70-80% present in advanced stage. The study aims to assess symptom burden and quality of life (QOL) in advanced incurable HNCa patients at presentation. Materials and Methods: One hundred patients were asked to fill EORTC QLQ-C15-PAL questionnaire, which consisted of Global QOL, physical functioning (PF), emotional functioning (EF), fatigue (FA), nausea-vomiting (NV), pain (PA), dyspnea (DY), sleep (SL), appetite (AP), and constipation (CO). Additional questions pertaining to swallowing (SW), hoarseness (HO), cough (CG), weight loss (WL), using pain killers (PK), taste (TA), bleeding (BL), hearing (HE), pain in neck lump (PALMP), opening mouth (OM), and oral secretions (OS) were asked based on a modified EORTC-HN35 questionnaire. Scoring was according to EORTC scoring manual. Mean, median and range were calculated for each item for the entire cohort. Results: The female:male ratio was 17:83.42% of them were ≥60 years of age. Sixty-six patients had T4, 25 had T3, 36 had N2, and 33 had N3 disease. Median QOL was 50 (range 0-83.33) and PF was 77.78 (0-100). Median score for EF and FA was 50. Median score for PA, PK, and SL was 66.67 while that for AP was 33.33. Median value for SW, HO, WL, BL, PALMP, OM, and OS was 33.33 (100-0) while TA, CG, NV, DY, and HE had a median score of 0.00. Conclusion: Advanced HNCa has a significant burden of symptoms. These results would help in giving patients better symptom directed therapies and improve their QOL.

Indian Council of Medical Research consensus document for the management of buccal mucosa cancer

evidence pertaining to Indian population and is meant for practice in India.• Evaluation of a patient with newly diagnosed buccal mucosa cancer should include essential tests: Biopsy of the primary lesion, complete blood counts, renal function tests and liver function tests, chest X-ray, dental evaluation, and ultrasonogram (USG) of the neck in patients with no clinically enlarged neck nodes. Computed tomography (CT) magnetic resonance imaging (MRI)/positron emission tomography (PET)-CT are not recommended for all patients.• For early stage disease (I/II), single modality treatment with surgery (with or without postoperative radiotherapy (PORT) or radiotherapy (RT) (brachytherapy or external beam radiotherapy [EBRT] or in combination) is recommended.• For locally advanced Stage (III–IV A), surgery followed by RT with or without chemotherapy, concurrent chemo-RT, altered fractionation RT schedules, induction chemotherapy, followed by surgery with or without RT are valid treatment options.• Stage IV B/metastatic diseases are treated with intent of palliation with chemotherapy and/or RT along with best supportive care.• Clinical examinationincludinghistoryandphysical isdoneateachfollow-up visit and no routine radiological investigation is recommended.

Role of gefitinib in patients with recurrent or metastatic cervical carcinoma ineligible or refractory to systemic chemotherapy: first study from Asia.

Objectives There are limited options for patients with recurrent or metastatic cervical carcinoma who are either refractory to or ineligible for systemic chemotherapy. We conducted a clinical study to evaluate the role of gefitinib, an epidermal growth factor receptor tyrosine kinase inhibitor, in such patients. Methods Eligible patients were enrolled into the study and were treated with gefitinib at a dose of 250 mg/day orally until disease progression, development of intolerable adverse effects, or withdrawal of consent. The primary end point of the study was progression-free survival. The secondary end points were stable disease, overall survival, and toxicity. Results From January 2008 to June 2011, a total of 20 patients were enrolled. Median age was 52 years and median disease-free interval was 15 months. Twelve patients presented with locoregional recurrence, 2 patients presented with distant metastases, and 6 patients presented with both locoregional recurrence and distant metastasis. Median duration of gefitinib therapy was 4 months. One patient had complete response, 1 patient had partial response, 4 patients had stable disease, and 14 patients had progressive disease. The median progression-free survival and overall survival were 4 months and 5 months, respectively. Only 1 patient had severe drug-related toxicity. Conclusions Gefitinib is safe and seems to be effective in recurrent or metastatic cervical carcinoma. Further studies are warranted to identify the subgroup of patients, based on epidermal growth factor receptor mutations, who are more likely to benefit.

The power of integration: radiotherapy and global palliative care.

Radiotherapy (RT) is a powerful tool for the palliation of the symptoms of advanced cancer, although access to it is limited or absent in many low- and middle-income countries (LMICs). There are multiple factors contributing to this, including assumptions about the economic feasibility of RT in LMICs, the logical challenges of building capacity to deliver it in those regions, and the lack of political support to drive change of this kind. It is encouraging that the problem of RT access has begun to be included in the global discourse on cancer control and that palliative care and RT have been incorporated into national cancer control plans in some LMICs. Further, RT twinning programs involving high- and low-resource settings have been established to improve knowledge transfer and exchange. However, without large-scale action, the consequences of limited access to RT in LMICs will become dire. The number of new cancer cases around the world is expected to double by 2030, with twice as many deaths occurring in LMICs as in high-income countries (HICs). A sustained and coordinated effort involving research, education, and advocacy is required to engage global institutions, universities, health care providers, policymakers, and private industry in the urgent need to build RT capacity and delivery in LMICs.