Accelerated hypofractionated radiotherapy with concomitant chemotherapy in locally advanced squamous cell carcinoma of lung: evaluation of response, survival, toxicity and quality of life from a Phase II randomized study.

Objective: To evaluate the feasibility and efficacy of accelerated hypofractionated radiation with concomitant chemotherapy (AHFx-RT-CT) in locally advanced squamous cell carcinoma (SCC) of the lung.

Methods: 36 patients were enrolled in this study (CTRI/2013/11/004143). Patients in Arm A (n = 18) received neoadjuvant chemotherapy (NACT) (paclitaxel 200 mg m(-2) and carboplatin area under the curve 5) followed by external radiotherapy (60 Gy/30 fractions/6 weeks). Patients in Arm B (n = 18) received NACT as in Arm A followed by AHFx-RT (48 Gy/20 fractions/4 weeks) with concomitant chemotherapy (cisplatin 30 mg m(-2) weekly). Primary end points included comparative evaluation of overall locoregional response rates (ORRs) and progression-free survival (PFS). Secondary end points included toxicity, quality of life (QOL) and overall survival (OS).

Results: The median follow-up duration was 15 months. The ORR at first follow-up (72.2% vs 44%, p = 0.06) and at 1 year after treatment completion (61% vs 5.5%, p = 0.04) were superior in Arm B. The median PFS (17 vs 5.36 months; p = 0.053) and OS (24.73 vs 12.33 months; p = 0.007) were also superior in Arm B. Grade ≥3 acute pharyngitis/oesophagitis was less in Arm B (p = 0.05). Improvement of emotional function, cognitive function and chest pain was observed in Arm B.

Conclusion: The study suggests that AHFx-RT-CT is feasible for locally advanced SCC of the lung with improved response rate, survival, QOL and favourable toxicity.

Advances In Knowledge: To the best of our knowledge, this is the first study comparing conventionally fractionated radiation with AHFx-RT-CT. Addition of low-dose weekly cisplatin as radiosensitizer may be the potential factor responsible for improved response rate, survival and favourable toxicity in the study arm despite lower biological effective dose.