BACKGROUNDThe objective of this study was to report the results of a Phase I dose‐escalation study using three‐dimensional conformal radiation therapy (3D‐CRT) for the treatment of patients with nonsmall cell lung carcinoma (NSCLC).METHODSBetween 1991 and 2003, 104 patients were enrolled for 3D‐CRT at Memorial Sloan‐Kettering Cancer Center. The median patient age was 69 years. Twenty‐eight percent of patients had Stage I–II NSCLC, 33% of patients had Stage IIIA NSCLC, 32% of patients had Stage IIIB NSCLC, and 6% of patients had recurrent NSCLC. Induction chemotherapy was received by 16% of patients. Radiation was delivered in daily fractions of 1.8 grays (Gy) for doses ≤ 81.0 Gy and in daily fractions of 2.0 Gy for higher doses. Accrual at a dose level was complete when 10 patients received the intended dose without unacceptable acute morbidity.RESULTSAfter an incident of fatal acute radiation pneumonitis at the starting dose of 70.2 Gy, the protocol was modified to limit normal tissue complication probabilities (NTCP) to < 25%. The dose was then escalated from 70.2 Gy, to 75.6 Gy, 81.0 Gy, and 84.0 Gy, with at least 10 patients treated at each dose level. Unacceptable pulmonary toxicity occurred at 90.0 Gy. Subsequently, another 10 patients were accrued at the 84.0 Gy level with acceptable toxicity. Thus, 84.0 Gy was the maximum tolerated dose (MTD). The crude late pulmonary toxicity rate was 7%, the 2‐year local control rate was 52%, the disease‐free survival rate was 33%, and the overall survival rate was 40%. The median survival was 21.1 months. Overall survival was improved significantly in patients who received ≥ 80.0 Gy.CONCLUSIONSThe MTD of 3D‐CRT for NSCLC with an NTCP constraint of 25% was 84.0 Gy in the current study. There was a suggestion of improved survival in patients who received 80.0 Gy. Cancer 2005. © 2005 American Cancer Society.

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Purpose/Objectives Re-irradiation (re-RT) is the only potentially curative treatment option for patients with locally recurrent head and neck cancer (HNC). Given the significant morbidity with head and neck re-irradiation, interest in proton beam radiotherapy (PBRT) has increased. Herein, we report the first multi-institutional clinical experience using curative intent PBRT for re-RT in recurrent HNC. Materials/Methods A retrospective analysis of ongoing prospective data registries from 2-hybrid community practice and academic proton centers was conducted. Patients with recurrent HNC who had at least one prior course of definitive intent external beam RT were included. Acute and late toxicities were assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 and by the Radiation Therapy Oncology Group late radiation morbidity scoring system, respectively. The cumulative incidence of locoregional failure was calculated with death as a competing risk. The actuarial twelve-month freedom from distant metastasis (FFDM) and overall survival (OS) rates were calculated with the Kaplan-Meier method. Results Ninety-two consecutive patients were treated with curative intent re-RT with PBRT between 2011 and 2014. Median follow-up among surviving patients was 13.3 months and among all patients was 10.4 months (interquartile range, 5.3-17.5 months). The median time between last RT and PBRT was 34.4 months. There were 76 patients with one prior RT course and 16 with two or more courses. Median PBRT dose was 60.6 Gy (RBE). Eighty-five percent of patients had prior HNC RT for an oropharynx primary and 39% had salvage surgery prior to re-RT. The cumulative incidence of locoregional failure at 12-months, with death as a competing risk, was 25.1%. Actuarial 12-month FFDM and OS were 84.0% and 65.2%, respectively. Acute grade ≥3 toxicities included mucositis (9.9%), dysphagia (9.1%), esophagitis (9.1%), and dermatitis (3.3%). There was one death during PBRT secondary to disease progression. Grade 3 or greater late skin and dysphagia toxicity were noted in 6 (8.7%) and 4 (7.1%) of patients, respectively. Two patients had grade 5 toxicity secondary to treatment-related bleeding. Conclusions Proton beam re-irradiation of the head and neck can provide effective tumor control with acceptable acute and late toxicity profiles likely secondary to the decreased dose to the surrounding normal, albeit previously irradiated tissue, though longer follow up is needed to confirm these findings.

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