Concurrent Chemo-Proton Therapy Using Adaptive Planning for Unresectable Stage 3 Non-Small Cell Lung Cancer: A Phase 2 Study.

Abstract

PURPOSE:

This study prospectively evaluated the efficacy and safety of concurrent chemo-proton therapy (CCPT) using adaptive planning for unresectable stage III non-small cell lung cancer (NSCLC).

METHODS AND MATERIALS:

The primary endpoint was overall survival (OS). Secondary endpoints were local control rate (LCR), progression-free survival (PFS), incidence of grade 3 or higher adverse events, and changes in quality of life (QOL). Patients received cisplatin (60 mg/m2) on day 1 and S-1 (∼40 mg/m2 twice daily) on days 1 to 14, q4w, for up to 4 cycles, plus concurrent proton therapy at a total dose of 70 GyRBE for the primary lesion and 66 GyRBE for lymph node metastasis with 2 GyRBE per day. Proton therapy was performed using respiratory-gated and image guided techniques, and adaptive plans were implemented.

RESULTS:

Forty-seven patients were enrolled between August 2013 and August 2018. Four cycles of cisplatin plus S-1 were completed in 34 patients. The mean number of cycles was 4 (range, 1-4). The median follow-up of all and surviving patients was 37 (range, 4-84) and 52 months (range, 26-84), respectively. The mean number of replanning sessions was 2.5 (range, 1-4). The 2- and 5-year OS, LCR, and PFS were 77% (95% confidence interval 64%-89%) and 59% (43%-76%), 84% (73%-95%) and 61% (44%-78%), and 43% (28%-57%) and 37% (22%-51%), respectively. The median OS was not reached. No grade 3 or higher radiation pneumonitis was observed. There was no significant deterioration in the QOL scores after 24 months except for alopecia.

CONCLUSIONS:

CCPT with adaptive planning was well tolerated and yielded remarkable OS for unresectable stage III NSCLC.

• Authors: Hiromitsu Iwata, Kenji Akita, Yusuke Yamaba, Eiji Kunii, Osamu Takakuwa, Misuzu Yoshihara, Yukiko Hattori, Koichiro Nakajima, Kensuke Hayashi, Toshiyuki Toshito, Hiroyuki Ogino, Yuta Shibamoto
• Journal: International journal of radiation oncology, biology, physics (Int J Radiat Oncol Biol Phys) Vol. 109 Issue 5 Pg. 1359-1367 (04 01 2021) ISSN: 1879-355X [Electronic] United States
• PMID: 33227444 (Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2020 Elsevier Inc. All rights reserved.

Chemical References

• Antineoplastic Agents
• Drug Combinations
• Radiation-Sensitizing Agents
• S-1 plus cisplatin
• Cisplatin

Topics

• Adult
• Aged
• Antineoplastic Agents (administration & dosage)
• Carcinoma, Non-Small-Cell Lung (mortality, pathology, therapy)
• Chemoradiotherapy (adverse effects, methods)
• Cisplatin (administration & dosage)
• Confidence Intervals
• Drug Administration Schedule
• Drug Combinations
• Female
• Follow-Up Studies
• Humans
• Lung Neoplasms (mortality, pathology, therapy)
• Male
• Middle Aged
• Progression-Free Survival
• Prospective Studies
• Proton Therapy
• Quality of Life
• Radiation-Sensitizing Agents (administration & dosage)
• Radiotherapy Planning, Computer-Assisted (methods)
• Radiotherapy, Image-Guided (methods)
• Remission Induction (methods)
• Time Factors