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

Autor: Hiromitsu Iwata, Misuzu Yoshihara, Toshiyuki Toshito, Eiji Kunii, Yusuke Yamaba, Kensuke Hayashi, Yuta Shibamoto, K. Nakajima, Y. Hattori, Hiroyuki Ogino, Kenji Akita, Osamu Takakuwa
Rok vydání: 2021
Předmět:
Adult
Male
Radiation-Sensitizing Agents
Cancer Research
medicine.medical_specialty
Lung Neoplasms
Time Factors
Urology
Phases of clinical research
Antineoplastic Agents
Drug Administration Schedule
030218 nuclear medicine & medical imaging
03 medical and health sciences
0302 clinical medicine
Quality of life
Carcinoma
Non-Small-Cell Lung

Confidence Intervals
Proton Therapy
medicine
Clinical endpoint
Humans
Radiology
Nuclear Medicine and imaging

Prospective Studies
Stage (cooking)
Adverse effect
Lung cancer
Aged
Radiation
business.industry
Radiotherapy Planning
Computer-Assisted

Incidence (epidemiology)
Remission Induction
Chemoradiotherapy
Middle Aged
medicine.disease
Progression-Free Survival
Confidence interval
Drug Combinations
Oncology
030220 oncology & carcinogenesis
Quality of Life
Female
Cisplatin
business
Follow-Up Studies
Radiotherapy
Image-Guided
Zdroj: International Journal of Radiation Oncology*Biology*Physics. 109:1359-1367
ISSN: 0360-3016
Popis: 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.
Databáze: OpenAIRE