Michael Kreuter1, Johan Vansteenkiste2, Jürgen R Fischer3, Wilfried E Eberhardt4, Heike Zabeck5, Jens Kollmeier6, Monika Serke7, Norbert Frickhofen8, Martin Reck9, Walburga Engel-Riedel10, Silke Neumann11, Michiel Thomeer12, Christian Schumann13, Paul De Leyn14, Thomas Graeter15, Georgios Stamatis16, Frank Griesinger17, Michael Thomas18. 1. Pneumology, Thoraxklinik, University of Heidelberg, Heidelberg, Germany; Translational Lung Research Center Heidelberg, German Center for Lung Research, Heidelberg, Germany. Electronic address: kreuter@uni-heidelberg.de. 2. Respiratory Oncology Unit (Pneumology Department), University Hospital KU Leuven, Leuven, Belgium. 3. Department of Internal Medicine II, Oncology, Klinik Loewenstein, Lowenstein, Germany. 4. Department of Medical Oncology, University Hospital Essen, West German Cancer Centre, Ruhrlandklinik, University of Duisburg-Essen, Germany. 5. Department of Thoracic Surgery, Thoraxklinik, University of Heidelberg, Heidelberg, Germany. 6. Department of Pneumology, Lungenklinik Heckeshorn, HELIOS-Klinikum Emil von Behring, Berlin, Germany. 7. Department of Pneumology III, Lungenklinik Hemer, Hemer, Germany. 8. Department of Hematology/Oncology, Dr.-Horst-Schmidt-Kliniken GmbH, Wiesbaden, Germany. 9. Department of Thoracic Oncology, Lungen Clinic Grosshansdorf, Airway Research Center North (ARCN), member of the German Center for Lung Research (DZL), Grosshansdorf, Germany. 10. Lungenklinik Merheim, Kliniken der Stadt Köln, Cologne, Germany. 11. Department of Hematology and Oncology, Georg-August-Universität, Göttingen, Germany and Interdisciplinary Center for Oncology, Wolfsburg, Germany. 12. Department of Respiratory Medicine Ziekenhuis Oost Limburg, Genk, Belgium. 13. Department of Internal Medicine II, University Clinic Ulm, and Clinic for Pneumology, Thoracic Oncology, Sleep- and Respiratory Critical Care, Kempten and Immenstadt, Germany. 14. Department of Thoracic Surgery, Universities Hospital Leuven, Leuven, Belgium. 15. Department of Thoracic Surgery, Klinik Loewenstein, Loewenstein, Germany. 16. Department of Thoracic Surgery, Ruhrlandklinik Essen, University Hospital of University Duisburg-Essen, Essen, Germany. 17. Department of Hematology and Oncology, Pius-Hospital Oldenburg, Oldenburg, Germany. 18. Thoracic Oncology, Thoraxklinik, University of Heidelberg, Heidelberg, Germany; Translational Lung Research Center Heidelberg, German Center for Lung Research, Heidelberg, Germany.
Abstract
INTRODUCTION:Adjuvant chemotherapy in non-small cell lung cancer (NSCLC) improves survival but is associated with significant toxicity. The Randomized Phase II Trial on Refinement of Early-Stage NSCLC Adjuvant Chemotherapy with Cisplatin and Pemetrexed versus Cisplatin and Vinorelbine (TREAT study) was designed to test the hypothesis that a protocol with reduced toxicity might improve feasibility of postoperative delivery of adjuvant chemotherapy drugs to patients with NSCLC, thereby improving compliance and, potentially, survival. METHODS: Two adjuvant regimens were evaluated for feasibility in 132 patients with NSCLC: the standard regimen of cisplatin and vinorelbine (CVb) (cisplatin 50 mg/m(2) on day 1 and day 8 and vinorelbine 25 mg/m(2) on days 1, 8, 15, and 22 every 4 weeks) and a regimen consisting of cisplatin and pemetrexed (CPx) (cisplatin 75 mg/m(2) and pemetrexed 500 mg/m(2) on day 1 every 3 weeks). The primary end-point analysis showing that CPx is safe and feasible with dose delivery superior to that of CVb has already been published. Here we report the 3-year follow-up results of the secondary efficacy end points-overall, relapse-free, distant metastasis-free, and local relapse-free survival-also with regard to histologic diagnosis. RESULTS: After a median of 39 months, no significant differences in any of the outcome parameters between CVb and CPx were observed. Also, histologic diagnosis and tumor size in stage IB did not influence survival in the CPx-treated patients. Yet, Cox regression analyses showed that overall survival at 3 years was significantly correlated with feasibility and the occurrence of dose-limiting toxicity. CONCLUSIONS: Although adjuvant chemotherapy with CPx is safe and characterized by less toxicity and better dose delivery than CVb, overall survival was not influenced by treatment arm in the context of this phase II trial.
RCT Entities:
INTRODUCTION: Adjuvant chemotherapy in non-small cell lung cancer (NSCLC) improves survival but is associated with significant toxicity. The Randomized Phase II Trial on Refinement of Early-Stage NSCLC Adjuvant Chemotherapy with Cisplatin and Pemetrexed versus Cisplatin and Vinorelbine (TREAT study) was designed to test the hypothesis that a protocol with reduced toxicity might improve feasibility of postoperative delivery of adjuvant chemotherapy drugs to patients with NSCLC, thereby improving compliance and, potentially, survival. METHODS: Two adjuvant regimens were evaluated for feasibility in 132 patients with NSCLC: the standard regimen of cisplatin and vinorelbine (CVb) (cisplatin 50 mg/m(2) on day 1 and day 8 and vinorelbine 25 mg/m(2) on days 1, 8, 15, and 22 every 4 weeks) and a regimen consisting of cisplatin and pemetrexed (CPx) (cisplatin 75 mg/m(2) and pemetrexed 500 mg/m(2) on day 1 every 3 weeks). The primary end-point analysis showing that CPx is safe and feasible with dose delivery superior to that of CVb has already been published. Here we report the 3-year follow-up results of the secondary efficacy end points-overall, relapse-free, distant metastasis-free, and local relapse-free survival-also with regard to histologic diagnosis. RESULTS: After a median of 39 months, no significant differences in any of the outcome parameters between CVb and CPx were observed. Also, histologic diagnosis and tumor size in stage IB did not influence survival in the CPx-treated patients. Yet, Cox regression analyses showed that overall survival at 3 years was significantly correlated with feasibility and the occurrence of dose-limiting toxicity. CONCLUSIONS: Although adjuvant chemotherapy with CPx is safe and characterized by less toxicity and better dose delivery than CVb, overall survival was not influenced by treatment arm in the context of this phase II trial.
Authors: Cheol-Kyu Park; Hyung-Joo Oh; Seung Soo Yoo; Shin Yup Lee; Sang Hoon Lee; Eun Young Kim; Sung Yong Lee; Juwhan Choi; Min Ki Lee; Mi-Hyun Kim; Tae Won Jang; Chaeuk Chung; In-Jae Oh; Young-Chul Kim Journal: Transl Lung Cancer Res Date: 2022-08