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163 Background: In RTOG 85-01, patients with locally advanced esophageal and gastroesophageal junction (GEJ) cancer treated with concurrent chemoradiotherapy (CRT) had a median overall survival (OS) of 14 months and 5-year OS of 27%. Improving outcomes in these patients is an unmet need. We investigated the addition of oral metronomic chemotherapy (OMC) following definitive CRT. Methods: A randomized integrated phase II/III clinical trial (CTRI/2015/09/006204) in patients with squamous cell carcinoma of the esophagus or the GEJ who had completed definitive radical CRT within the past 12 weeks, had an ECOG PS 0-2 and no clinical or radiologic evidence of progressive disease. Patients were stratified based on whether or not they had received induction chemotherapy followed by CRT, and then randomized 1:1 to receive OMC (celecoxib 200 mg twice daily and methotrexate 15 mg/m2 weekly) for 12 months or observation. The primary efficacy endpoint for the phase II portion was progression free survival (PFS). The secondary endpoints were OS and toxicity. With a power of 70% and an alpha of 10%, we hypothesized a hazard ratio of 1.5, with a median follow-up of 6 months. The planned sample size for the phase II portion was 151 patients. The p-value for stopping the trial after the phase II part of the study was set at 0.2 for the PFS. Results: Between Jan 2016 and Dec 2019, we enrolled 151 patients, 75 to the OMC arm and 76 to observation. The median age was 57 years, 59% were male. The tumor originated in the upper thoracic esophagus in 79% patients, with median tumor length 6 cm. Induction chemotherapy was received by 14% of the patients. Concurrent CRT consisted of median 63 Gy in median 35 fractions; 91% patients received concurrent weekly paclitaxel and carboplatin with radiation. OMC was started at a median of 11 weeks (IQR, 9 to 12) from the start of CRT. Grade 3 or higher toxicities (regardless of relatedness to study intervention) were noted in 27 patients (17.9%), 18 in the OMC arm and 9 in the observation arm; P=0.071. The median time to disease progression or death was 23 months (95% CI, 7.9-38.1) in the OMC arm and not reached in the observation arm; HR, 1.33, 95% CI, 0.83-2.14; P=0.23. The 1-year PFS was 67% in both the arms; the 2-year PFS were 48% and 61% in the OMC and observation arms respectively. The median OS was 36 months (95% CI, 17.9-54) in the OMC arm and not reached in the observation arm; HR, 1.75; 95% CI, 1.02-2.99; P, 0.037. The 1-year OS was 74.7% in the OMC arm and 88% in the observation arm; the 2-year OS was 53.9% in the OMC arm and 75% in the observation arm. Conclusion: Adjuvant oral metronomic chemotherapy after radical CRT does not improve outcomes in patients with locally advanced esophageal or GEJ squamous cell carcinoma. Clinical trial information: CTRI/2015/09/006204.

Purpose: Respiratory-induced tumor motion is a major challenge in lung cancer (LC) radiotherapy. Four-dimensional computed tomography (4D-CT) using a maximum intensity projection (MIP) dataset is a commonly used and time-efficient method to generate internal target volume (ITV). This study compared ITV delineation using MIP or tumor delineation on all phases of the respiratory cycle. Materials and Methods: Thirty consecutive patients of LC who underwent 4D-CT from January 2014 to March 2017 were included. ITV delineation was done using MIP (ITVMIP) and all ten phases of the respiratory cycle (ITV10Phases). Both volumes were analyzed using matching index (MI). It is the ratio of the intersection of two volumes to the union of two volumes. A paired sample t-test was used for statistical analysis, and P < 0.05 was considered statistically significant. Results: The mean ± standard deviation volume of ITV10Phases was significantly larger compared to ITVMIP (134 cc ± 39.1 vs. 113 cc ± 124.2, P = 0.000). The mean MI was 0.75 (range 0.57–0.88). The mean volume of ITV10Phases not covered by ITVMIP was 26.33 cc (23.5%) and vice versa was 5.51 cc (6.1%). The mean MI was 0.73 for tumors close to the mediastinum, chest wall, and diaphragm. MI was not different between tumors ≤5 cm and >5 cm. The average time required for delineation was 9 and 96 min, respectively. The center of mass of two ITVs differed by 0.01 cm. Conclusion: ITV using MIP is significantly smaller and may miss a tumor compared to ITV delineation in 10 phases of 4D-CT. However, the time required is significantly less with MIP. Caution should be exercised in tumors proximity to the mediastinum, chest wall, and diaphragm.

Stereotactic body radiotherapy (SBRT) is now considered the standard treatment for medically inoperable early-stage non-small lung cell cancer (ES-NSCLC).There is a paucity of data related to outcomes with SBRT in ES-NSCLC from the developing countries. We report the early outcomes of ES-NSCLC patients treated with SBRT at our institute.Between 2007 and 2015, 40 consecutive patients with histologically proven ES-NSCLC were treated with SBRT. Median age was 71 years (range: 46-88 years) and median Charlson comorbidity index (CCI) was 3. The majority had stage I (70%) and 45% of the tumors were centrally located. The median tumor diameter was 3.8 cm (range: 2-7.6 cm). The mean gross tumor volume was 41 cc (range: 4-139 cc) and the mean planning target volume (PTV) was 141 cc (range: 27-251 cc). Varying dose and fraction (fr) sizes were used depending on tumor location, tumor size, and treatment period. The median biologically effective dose (BED) was 77 GyAfter a median follow-up of 16 months (range: 3-99 months), the 2-year local control (LC), overall survival, and cancer-specific survival (CSS) rates were 94%, 41%, and 62%, respectively. The univariate and multivariate analysis determined CCI3 and PTV80.6 cc as significant predictors of worse OS and CSS (P0.01). The clinical stage, tumor location, BED, and treatment period (2007-2012 vs. 2013-2015) did not significantly predict any of the outcomes. The most common acute toxicities were skin erythema (10%), grade 1 esophagitis (8%), and exacerbation of previous chronic obstructive pulmonary disease (10%). Grade ≥2 late radiation pneumonitis was seen in 17.5%. One patient developed a rib fracture. No neurological or vascular complications were seen.SBRT results in excellent local control (LC) and acceptable survival in medically inoperable ES-NSCLC with minimal adverse effects. Charlson comorbidity index and target volume are important prognostic factors and may aid in patient selection.

The novel coronavirus (COVID-19) pandemic has disrupted healthcare delivery across the globe. Cancer patients are at a higher risk of acquiring this infection due to their immunosuppressed state. Timely care of patients while ensuring safety of healthcare workers is need of the hour. We list few precautionary measures that can be taken at all radiotherapy centres, during the pandemic to curb and combat the spread of this disease.

Aims The role of whole brain radiotherapy (WBRT) in patients with brain metastases from non-small cell lung cancers (NSCLC) has been questioned. However, no reliable criteria exist to identify patients who do not benefit from WBRT. The objective of the current study was to develop a prognostic model to identify such patients whose survival matches that of the Quality of Life after Treatment for Brain Metastases (QUARTZ) study. Materials and methods Outcome data of patients with NSCLC with brain metastases undergoing WBRT enrolled in a prospective observational study in a tertiary cancer centre were used to develop a prognostic model. Baseline clinico-radiological factors were used for development of the model. The model was internally validated and calibration accuracy was checked for prediction of 70 day mortality. The generated prognostic model was presented as a nomogram. Results The median overall survival of 140 patients enrolled in the study was 166 days (95% confidence interval 108–242 days). The prognostic model identified gender, Karnofsky performance status and epidermal growth factor receptor activating mutation status as significant factors influencing overall survival. The model showed a modest discriminative ability with an optimism-corrected C-index of 0.64. However, model calibration error did reveal a moderate degree of calibration error. The high-risk subgroup identified by the model had a median overall survival of 67 days (95% confidence interval 56–101 days), which was similar to that observed in the QUARTZ trial. Conclusion This prognostic model derived from traditional clinico-radiological features had a modest ability to identify patients with poor prognosis who may not benefit from WBRT. However, the high-risk subgroup identified using this prognostic model had a survival similar to that observed for patients in the QUARTZ trial.

Introduction Our aim was to investigate the added prognostic value of a patient-reported functional outcome score over Karnofsky Performance Status (KPS) in patients with non-small-cell lung cancers (NSCLC) with brain metastases. Materials and methods The baseline data are from a prospective cohort study involving 140 consecutive patients presenting at our institute. A patient reported performance status (PRPS) was obtained by summing the physical- and role-functioning scale scores of the EORTC QLQ C30 questionnaire. Nested cox proportional hazards models predicting survival were developed including both KPS and PRPS (full model), KPS only (KPS Model), and PRPS only (PRPS model). The incremental value of the addition of KPS or PRPS was ascertained using the likelihood ratio test, model adequacy index and integrated discrimination Improvement (IDI). Results PRPS was an independent and statistically significant prognostic factor and had only a moderate degree of agreement with KPS. All models showed nearly the same discrimination and calibration accuracy, but the likelihood ratio test comparing the full model to the KPS model was significant (L.R. Chi2 = 5.34, p = 0.02). Model adequacy index for the KPS model was 85% versus 95% for the PRPS model. IDI when comparing the KPS model to the full model was 0.0279, while it was 0.008 for the PRPS model versus the Full model. Conclusions Use of patient-reported functional outcomes like PRPS can provide the same prognostic information as KPS in patients of NSCLC with brain metastases. Highlights Patient-reported functional status (PRPS) has a moderate degree of agreement with KPS.PRPS is an independent and significant predictor of survival in brain metastases.PRPS can replace KPS without loss of prognostic information.

INTRODUCTION Reference data for European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaires do not include studies from the Indian subcontinent. The objective of the current study was to establish a reference dataset for Indian patients of non-small cell lung cancer (NSCLC) presenting with brain metastases (BM). MATERIAL AND METHODS One hundred forty patients with NSCLC with BM treated between 2012-2015 were registered in a prospective cohort study (CTRI/2013/01/003299). The baseline quality of life was evaluated using the EORTC general quality of life questionnaire QLQ-C30 and lung cancer specific module LC13. Minimum important difference (MID) scores for individual domains of the EORTC QLQ-C30 and LC13 questionnaires were derived (MID = 0.2 x standard deviation) from the reference data for patients with recurrent/metastatic lung cancers. In addition, a systematic review was conducted to identify studies reporting baseline quality of life scores for recurrent/metastatic NSCLC. RESULTS Scores of several functional as well as symptom scales in the current NSCLC population differed by more than the MID from the baseline mean scores in the reference EORTC population as well as that reported from other studies. Differences in mean score from the EORTC reference data ranged from 6.2 and 9.4 points for the role functioning and cognitive functioning domains. In the symptom scales, the largest differences were observed for the financial difficulties (23.9) scores for the QLQ-C30 and peripheral neuropathy (21.7) for LC13 questionnaires. CONCLUSION The current study demonstrates that baseline reference scores need to be established for patients from the Indian subcontinent. The findings from the current study have important implications for studies employing quality of life (QOL) assessment in the Indian NSCLC patient population.

Background Management of brain metastasis is a complex multidisciplinary venture. Hence, we started a multidisciplinary brain metastasis clinic for opinion on difficult brain metastasis cases. This is the review of the impact of this clinic on the treatment decisions. Methods Brain metastasis clinic (BMC) was started in the month of April 2018 and meets once a week. Data of patients discussed between 27th April 2018 to 28th June 2019 were included for thisanalysis. Treatment decision made by clinicians (before sending the patient to the BMC were compared with the decisions made in BMC. The decisions were broken on a predefined proforma as intent of treatment (curative or palliative), modalities planned (surgery, radiation, chemotherapy), type of therapy planned (details of each therapy) in each modality were collected both pre and post BMC. In addition, compliance of the respective physicians to BMC decision was also calculated. SPSS version 20 was used for analysis. Descriptive statistics was performed. Results Ninety-nine patients were discussed in this time period. The median age was 51 (range 17-68) years. The gender distribution was 70 males (70.7%) and 29 females (29.3%). Lung was thepredominant site of malignancy (79, 79.8%). Thirty-one patients (31.3%) had EGFR TKI domain activating mutation while 17 (17.2%) had ALK rearrangement. The treatment plan was changed in 46 patients (46.5%). The intent of treatment was changed in 5 patients (5.3%). Change in treatment plan with respect to surgery in 9 patients (9.1%), radiation in 37 patients (37.4%), chemotherapy in 15 patients (15.2%), targeted therapy in 11 patients (22.9%) and intrathecal in 6 patients (6.1%) respectively. The compliance to the BMC decision in patients in whom it was changed was 84.8% (39, n = 46). Conclusions Multidisciplinary management of difficult brain metastasis cases in specialized clinics has significant impact on treatment decisions. Legal entity responsible for the study Tata Memorial Hospital, Mumbai. Funding Has not received any funding. Disclosure All authors have declared no conflicts of interest.

Objective: The objective of this study is to evaluate the diagnostic and prognostic ability of fluorodeoxyglucose positron emission tomography-computed tomography (FDG PET-CT) scan in patients with squamous cell carcinoma of the head and neck treated with chemoradiotherapy or radiotherapy only. Materials and Methods: Fifty-nine patients with HNSCC planned for radical nonsurgical treatment were randomized to receive either three-dimensional conformal radiotherapy or intensity-modulated radiation therapy. In addition to routine clinical examination and staging investigations, patients had a FDG PET-CT scan at baseline and on the first follow-up for response assessment. No evidence of clinicopathological disease for at least 6 months after the completion of treatment was considered confirmation of complete response. The presence or absence of disease during the follow-up period was used to calculate the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of PET-CT for the primary site and node. Results: At a median follow-up of 52.5 months, 55.6% of patients were alive and disease free. Response assessment PET-CT was done at a median of 9 weeks (range: 5–18 weeks). PET-CT assessment of the primary had sensitivity, specificity, PPV, and NPV of 81.8%, 93%, 75%, and 95.2%, respectively; the corresponding figures at the node were 44.4%, 95.6%, 66.7%, and 89.6%. The median baseline maximum standardized uptake value (SUVmax) at primary and node was 14.9 and 8.1, respectively. When PET-CT was done after 10 weeks, no false-positive or false-negative findings were seen. Patients with negative PET at the first follow-up had a significantly better progression-free and overall survival. Conclusions: Disease evaluation using PET-CT has an overall accuracy of 80%. High baseline SUVmax correlates with worse clinical outcomes. Negative PET-CT at the first follow-up is a predictor for survival.