Palliative radiotherapy and quality of life in patients with locally advanced thoracic esophageal cancer: a single centre experience from Central India.

Background: Patients with locally advanced esophageal squamous cell carcinoma (LAESCC ) have decreased quality of life (QoL) and, thus, require palliative external beam radiotherapy (EBRT). The present study was performed to evaluate the QoL in patients with LAESCC undergoing palliative EBRT. Materials and methods: This was a prospective, observational study performed over a period of 18 months (from December 2018 to May 2020) in the Department of Radiation Oncology. Seventy patients with LAESCC received EBRT (30 Gy in 10 fractions, at 3 Gy per fraction over 2 weeks). Patients were followed-up at monthly intervals for 3 months. The dysphagia and odynophagia scores were calculated at baseline and follow-up visits. The QoL was assessed with 18-item EORTC QLQ-OES questionnaire at baseline and 3 months. Results: Over the study period, significant decrease in mean dysphagia and odynophagia score was observed (p-value < 0.0001). On post-hoc analysis, significant decrease in both dysphagia and odynophagia score was observed between baseline and at the end of study and between various follow-up visits (p-value < 0.0001). Moreover, there was a significant increase in mean body weight (p-value < 0.0001). At 3 months, there was a significant decrease in dysphagia (p-value < 0.0001), eating (p-value < 0.0001), reflux (p-value = 0.005), pain (p-value < 0.0001), and saliva (p-value = 0.01) domains of EORTC QLQ-OES18 questionnaire. Conclusion: In patients with LAESCC, EBRT leads to significant decrease in dysphagia and odynophagia, and increase in body weight. These changes indirectly lead to improved QoL.

Efficacy, Safety, Pharmacokinetics, and Immunogenicity of DRL-Trastuzumab Versus Herceptin in Human Epidermal Growth Factor Receptor 2-Positive Metastatic Breast Cancer: A Randomized Controlled Trial.

PURPOSE: Dr Reddy's Laboratories Trastuzumab (DRL_TZ) is a biosimilar to Herceptin under development. The present study was conducted to evaluate efficacy, safety, pharmacokinetics (PKs), and immunogenicity of DRL_TZ in comparison with the reference medicinal product (RMP) along with concomitant weekly paclitaxel in patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC). METHODS: This was a randomized, double-blind study in female patients with HER2-positive MBC, randomly assigned in a 1:1 ratio to receive either DRL_TZ or the RMP, that is, an innovator product sourced from the European region, along with additional chemotherapy, as first-line treatment for up to 24 weeks. The primary end point was the best overall response rate (ORR) as per RECIST 1.1 criteria. Progression-free survival rate at 6 months (PFS6), safety, immunogenicity, and PK parameters were assessed as secondary end points. RESULTS: A total of 164 patients were randomly assigned to receive either DRL_TZ or the RMP. Best ORR in the per-protocol population was comparable, 91.9% (93.3% CI, 83.2 to 96.3) versus 82.1% (93.3% CI, 72.0 to 89.1) in DRL_TZ and RMP arms, respectively; the difference between the arms was 9.8% with a 93.3% CI of -1.3 to 20.8. The PFS6 rate, safety, PK profile, and antidrug antibody incidence were comparable. An additional 44 patients were recruited in the postrandomization phase, in an open-label manner, and started on DRL_TZ to generate more data on efficacy, safety, and immunogenicity. The additional data with DRL_TZ, when pooled, were similar to the RMP data. CONCLUSION: DRL_TZ was found to have similar efficacy and comparable safety, PK, and immunogenicity profiles as the RMP.

Comparison of Efficacy and Safety of a Bevacizumab Biosimilar, in Combination with Chemotherapies, in Nonresectable Metastatic Colorectal Cancer and in Advanced Nonsquamous Non-Small Cell Lung Cancer: A Randomized, Double-Blind, Phase III Study.

Ranjith K.The objective of this study was to compare the efficacy, safety, pharmacokinetics, and immunogenicity of a proposed bevacizumab biosimilar (DRL_BZ) with the innovator Avastin (reference medicinal product [RMP]) in patients with nonresectable metastatic colorectal cancer (mCRC) over a period of 9 months and advanced nonsquamous non-small cell lung cancer (NSCLC) over 6 months. The study was planned as a randomized, double-blind trial. In part A, a total of 117 mCRC patients were intended to receive 5 mg/kg of bevacizumab every 2 weeks along with mFOLFOX6 chemotherapy for a maximum of 18 cycles. In part B, 60 NSCLC patients were to receive 15 mg/kg of bevacizumab every 3 weeks along with pemetrexed and carboplatin for the initial four cycles, followed by pemetrexed for another four cycles. The primary endpoint was the progression-free survival rate at 6 months (PFS6) in both subparts. The anticipated sample size was 106 evaluable mCRC patients to achieve 85% statistical power for concluding noninferiority with a margin of half the difference (18.8%) between DRL_BZ and Avastin, along with a pilot study involving 60 evaluable NSCLC patients. Safety comparison included assessing adverse events (AEs), infusion reactions, and lab abnormalities. Immunogenicity comparison involved the incidence of antidrug antibodies (ADAs) and neutralizing antibodies (NAbs). Pharmacokinetic comparison was planned after the first and fourth dosing cycles of treatment in 24 NSCLC patients. The PFS6 for mCRC patients treated with DRL_BZ and RMP was 57.8% and 50% respectively, with a difference in efficacy of 7.8 (-8.7, 23.7). The PFS9 was 31.1% and 22.9%, with a difference of 8.2% (-6.9%, 22.9%). The objective response rate (ORR) for DRL_BZ and RMP was 28.8% and 22.4%, while the disease control rate (DCR) was 44.2% and 37.9% respectively. For NSCLC patients, the PFS6 was 44% and 45%, showing a difference of -1.0 (-4.2, 22.1). The ORR was 41.4% and 48.1%, and the DCR was 62.1% and 63%. The frequency, type, and severity of AEs were similar in both indications. Blood levels during the first and fourth dosing cycles exhibited comparable values. All NSCLC patients tested negative for ADA, while no mCRC patients on DRL_BZ tested positive for ADA. Low incidences of ADA (8%) and NAbs (4.0%) were reported in patients on RMP. Overall, the efficacy, safety, immunogenicity, and pharmacokinetic parameters of DRL_BZ and RMP were found to be comparable. Clinical Trial Registration For BZ-01-002: CTRI/2016/01/006481.

A study to evaluate resource draining "no shows".

INTRODUCTION: Waiting lists are problems that plague all government radiation therapy centers across the country, leading to disease progression, and reduced treatment efficacy. No shows for appointments create artificial access issues, reduce revenues, waste staff time, and negatively affect patient care. METHODOLOGY: A Retrospective analysis of 180 patients, who were given an appointment and were to be started for radiation therapy at the Department of Radiation Therapy and Oncology, at our institute from May 1, 2013 to July 31, 2013, was done. Patients were divided into two Groups; Group A (n = 104, 57.8%) that complied for treatment and Group B (n = 76, 42.2%) that did not comply for treatment on the scheduled date. The Group B ("no shows") patients were contacted telephonically and were evaluated for the primary reasons for their failure to comply for treatment through a preformed questionnaire. RESULTS: The mean age, gender distribution and patient's habitat in both the groups were comparable. On Group B analysis, the average waiting period for the appointment was 74 days; 31.4% had died within an average of 31 days; 37.1% said they were better; 10% said their condition was the same; 18.6% said their disease had progressed. Patients were also evaluated for various factors responsible for their not reporting for treatment at the institute. CONCLUSION: Better communication and constant reminders between patients and the departmental staff can go a long way in helping to curb the problem of no shows and mitigate the artificial access issues. This would lead to better patient care and better resource utilization.

Conventional vs concomitant boost radiotherapy with concurrent cisplatin in advanced head and neck cancer.

AIM OF STUDY: To compare outcome of concomitant boost therapy (CBT) with conventional radiotherapy with cisplatin as a radiosensitizer in advanced head and neck cancer. SUBJECTS AND METHODS: Prospective comparative study was undertaken. Patients were assigned alternately to ArmA (conventional arm) and ArmB (CBT arm), 30 in each arm and total 60 patients were enrolled. RESULTS: Out of 30 patients in conventional Arm A, 13 had complete response (CR; 43.33%), 9 had partial response (PR; 30%), three patients (10%) had stable disease (SD), and five patients (16.66%) had progressive disease (PD). In arm B out of 30 patients, 18 patients (60%) had CR, five patients (16.66%) had partial response (PR), four patients (13.33%) showed SD, and three patients (10%) had PD. There was no statistically significant difference between the two arms for CR (P - value = 0.196). CONCLUSIONS: CBT can be used as an alternative to conventional RT in advanced head and neck cancers which minimize the total duration and the workload can be reduced. The locoregional control with CBT is comparable with the response of conventional RT.

Malignant Melanoma Of Uterine Cervix In A Young Female.

Malignant melanoma is a rare cancer, its incidence being 1% of all cancers. Malignant melanoma of the female genital tract is even rarer with incidence of 3% to 7% of all malignant melanomas. It usually occurs in postmenopausal women. We present a case of malignant melanoma of the uterine cervix in a multiparous premenopausal 29 year old female. She underwent a modified radical hysterectomy. She was stage III and was treated with external beam radiotherapy to the pelvis followed by brachytherapy. Since then the patient was on regular follow up until she developed lung metastasis. Malignant melanoma of the cervix has very less data in literature. Through this case report we will emphasize on the role of radiotherapy in malignant melanoma of uterine cervix.

Assessing Role of Oral Glutamine Supplementation in Radiation Induced Oral Mucositis in Head and Neck Cancers

Background:Radiotherapy with or without concurrent chemotherapy forms the mainstay of treatment of head and neck cancers. Oral mucositis is one of the most common complications of Chemo Radio-Therapy(CRT) which outweighs the systemic complaints both in terms of severity and difficulty in management. The aim of our study was to assess the role of oral glutamine supplementation in prevention of oral mucositis in patients receiving CRT to the head and neck. Methods: This was a Prospective Randomized study performed between April 2017 to November 2017.Total 60 patients (30 in each arm) were enrolled. Patients in ARM A were advised to take Glutamine crystalline powder dissolved in water to be consumed daily within 1 hour before radiation and were again asked to repeat the same dose 7 to 8 hours post radiation. Glutamine Treatment was 5 days/week on Radio-therapy days only. Patients in ARM B were given Placebo twice a day in same fashion as ARM A.Weekly Cisplatin was given in both arms. Results: Average no of days for onset of mucositis in glutamine arm was 17 days vs 32 days in control arm. 26.67% of patients in the glutamine arm developed mucositis in the 5th to 6th week, whereas 60% patients in the control arm developed mucositis as early as the 3rd week. 13% of the patients in the glutamine arm developed G3 mucositis whereas 23.3% of patients in the control arm developed G3 mucositis. 46.6% percent of patients in the glutamine arm received complete six cycles of chemotherapy, whereas only 13.33% of the patients in the control arm could complete six cycles of chemotherapy(p<0.001) 93.3% of patients in the glutamine arm completed treatment within the stipulated period of 7 weeks, whereas only 33.3% patients in the control arm completed treatment within 7 weeks.(p<0.05). Conclusion: Glutamine significantly decreases the onset as well as the severity of mucositis in patients receiving CRT to the head and neck thus translating into lesser treatment gaps and improvement in patient quality of life.

Role of Neoadjuvant Chemotherapy followed by Concurrent Chemo-radiation in Locally Advanced Cervical Carcinoma: Our Experience

Background: Cervical carcinoma is the second most common cancer in females in India. Majority of them are reported in advanced stage. We have given platinum based neoadjuvant chemotherapy followed by CTRT in our study to reduce the local recurrence and decrease the tumor burden. The primary objective of our study was to assess the efficacy of NACT in terms of clinical and radiological response at the end of completion of treatment. Methods: This was a single arm prospective study in which we enrolled 79 patients from  2015-2017 who received 3 cycles of NACT, triweekly Cisplatin and 5-FU followed by concurrent chemo radiation (Radiotherapy-External beam radiotherapy 50Gy/25# plus intracavitary brachytherapy). Response was assessed at 12 weeks of completion of treatment by MRI pelvis using RECIST criteria 1.1 and toxicities were assessed weekly using CTCAE 4.03. Results: Mean age was 54 years; compliance rate was 88.6%. Complete response rate was 58.57% and partial response rate was 18.57% at 12 weeks post-treatment. Grade 2 or higher toxicities were seen in 52.85% patients during NACT and chemo radiation. Skin toxicities were seen in 37.14% followed by rectal-32.85%, haematological-27.14% and urinary bladder-24.28%. Conclusions: Neoadjuvant chemotherapy followed by Concurrent chemo radiation is a feasible treatment option with a good response rate with acceptable rate of treatment related toxicities.

Treatment Outcome Of External Beam Radiotherapy (EBRT) With Intracavitary Radiotherapy (ICRT) In Ca Cervix: An Institutional Experience

Introduction : Ca Cervix is the second most common malignancy in Indian women. Most of the cases present in advanced stage. Radiotherapy is an important modality of treatment. Combination of EBRT and ICRT is an effective strategy which is based on the principle that we are able to give high radiation dose to tumor while sparing surrounding normal tissue.Aim and Objectives :The aim was to evaluate the 3 year overall survival (OS) and disease-free survival (DFS) of patients treated by EBRT and ICRT. The objectives were to evaluate radiation toxicities and to evaluate rate of residual disease, recurrence and distant metastases.Materials and Methods : It is a Retrospective analytical study. We analyzed 468 newly diagnosed cases of Ca Cervix registered in department between January2009 to December2013. Out of which 382 completed radical radiotherapy (EBRT+ICRT).Results : At the end of 3 years 58(15.18%) patients lost to follow-up, 48(12.56%) residual disease, 60(15.70%) local recurrence and 26(6.80%) had distant metastases. The DFS was 73.91% in Stage-I and 62.8% in Stage-II while 51.38% in Stage-III and 29.82% in Stage-IV. The OS was 82.6% in Stage-I, 71.9% in Stage-II, 65.19% in Stage-III and 42.1% in Stage-IV. The difference between early and advanced disease is statistically significant with p-value of 0.016. Conclusions : EBRT and ICRT is effective treatment in terms of overall survival and disease-free survival. Associated radiation induced rectal and bladder toxicities are acceptable & manageable. Early stage and overall treatment time are favorable prognostic factors for 3 year DFS & OS.