Branislav Jeremic1, Elena Fidarova2, Vinay Sharma3, Mohammed Faheem4, Aly Azmy Ameira5, Chiraz Nasr Ben Ammar6, Ana Frobe7, FeeNee Lau8, Stephen Brincat9, Glenn Jones10. 1. Institute of Lung Diseases, Sremska Kamenica and BioIRC Research Centre, Kragujevac, Serbia. Electronic address: nebareje@gmail.com. 2. International Atomic Energy Agency, Vienna, Austria. 3. University of Witswatersrand, Johannesburg, South Africa. 4. Nuclear Medicine, Oncology and Radiotherapy Institute, Islamabad, Pakistan. 5. Misr Oncology Centre, Cairo, Egypt. 6. Institut National de Cancer Salah Azaiz, Tunis, Tunisia. 7. Sestre Milosrdnice Hospital, Zagreb, Croatia. 8. General Hospital, Kuala Lumpur, Malaysia. 9. Sir Paul Boffa Hospital, La Valetta, Malta. 10. University of Toronto, Canada.
Abstract
BACKGROUND: To optimize palliation in incurable locally advanced non-small cell lung cancer (NSCLC), the International Atomic Energy Agency conducted a prospective randomized study (NCT00864331) comparing protracted palliative radiotherapy (RT) course with chemotherapy (CHT) followed by short-course palliative RT. METHODS AND MATERIALS: Treatment-naive patients with histologically confirmed NSCLC, stage IIIA/IIIB, received either39Gy in 13 fractions as RT alone (arm A, n=31) or 2-3 platinum-based CHT cycles followed by 10Gy in a single fraction or 16Gy in 2 fractions separated by one week (arm B, n=34). Primary outcome was overall survival. RESULTS: Treatment groups were balanced with respect to various variables. Median survival for all 65 patients was 8months, while median survival was 7.1 and 8.1months for the two arms, respectively (log-rank p=0.4 by study arm, and p=0.6 by Cox regression and stratified by country and sub-stage). One and three year survival rates for the two arms were 29%, and 9% and 41%, and 6%, respectively. There were no differences in any of the following endpoints: any failure, local failure, regional failure, contralateral thoracic failure, and distant failure between the two arms. High-grade (⩾3) toxicity was similar between the two arms. Symptoms, adverse events of any kind, KPS and body-mass index, were not different during treatment and during follow-up. There was no grade 5 toxicity. CONCLUSIONS: This incomplete and underpowered trial only hinted similar outcome between the treatment arms. Therefore, combined CHT-RT can perhaps be considered, in limited resource setting, where access to RT remains inadequate.
RCT Entities:
BACKGROUND: To optimize palliation in incurable locally advanced non-small cell lung cancer (NSCLC), the International Atomic Energy Agency conducted a prospective randomized study (NCT00864331) comparing protracted palliative radiotherapy (RT) course with chemotherapy (CHT) followed by short-course palliative RT. METHODS AND MATERIALS: Treatment-naive patients with histologically confirmed NSCLC, stage IIIA/IIIB, received either 39Gy in 13 fractions as RT alone (arm A, n=31) or 2-3 platinum-based CHT cycles followed by 10Gy in a single fraction or 16Gy in 2 fractions separated by one week (arm B, n=34). Primary outcome was overall survival. RESULTS: Treatment groups were balanced with respect to various variables. Median survival for all 65 patients was 8months, while median survival was 7.1 and 8.1months for the two arms, respectively (log-rank p=0.4 by study arm, and p=0.6 by Cox regression and stratified by country and sub-stage). One and three year survival rates for the two arms were 29%, and 9% and 41%, and 6%, respectively. There were no differences in any of the following endpoints: any failure, local failure, regional failure, contralateral thoracic failure, and distant failure between the two arms. High-grade (⩾3) toxicity was similar between the two arms. Symptoms, adverse events of any kind, KPS and body-mass index, were not different during treatment and during follow-up. There was no grade 5 toxicity. CONCLUSIONS: This incomplete and underpowered trial only hinted similar outcome between the treatment arms. Therefore, combined CHT-RT can perhaps be considered, in limited resource setting, where access to RT remains inadequate.
Authors: Richard Simcock; Toms Vengaloor Thomas; Christopher Estes; Andrea R Filippi; Matthew A Katz; Ian J Pereira; Hina Saeed Journal: Clin Transl Radiat Oncol Date: 2020-03-24
Authors: Francesco Cellini; Rossella Di Franco; Stefania Manfrida; Valentina Borzillo; Ernesto Maranzano; Stefano Pergolizzi; Alessio Giuseppe Morganti; Vincenzo Fusco; Francesco Deodato; Mario Santarelli; Fabio Arcidiacono; Romina Rossi; Sara Reina; Anna Merlotti; Barbara Alicja Jereczek-Fossa; Angelo Tozzi; Giambattista Siepe; Alberto Cacciola; Elvio Russi; Maria Antonietta Gambacorta; Marta Scorsetti; Umberto Ricardi; Renzo Corvò; Vittorio Donato; Paolo Muto; Vincenzo Valentini Journal: Radiol Med Date: 2021-09-27 Impact factor: 3.469