Hypofractionated radiotherapy with weekly paclitaxel and carboplatin versus conventional fractionation radiotherapy with weekly cisplatin in carcinoma of the larynx and hypopharynx for response and toxicity assessment

Authors

  • Dhiraj Meshram Department of Radiation Oncology, Government Medical College and Cancer Hospital, Chatrapati Sambhaji Nagar, Aurangabad, Maharashtra, India
  • Balaji Shewalkar Department of Radiation Oncology, Government Medical College and Cancer Hospital, Chatrapati Sambhaji Nagar, Aurangabad, Maharashtra, India
  • Jitendra Patel Department of Radiation Oncology, Government Medical College and Cancer Hospital, Chatrapati Sambhaji Nagar, Aurangabad, Maharashtra, India
  • Punita Pant Department of Radiation Oncology, Government Medical College and Cancer Hospital, Chatrapati Sambhaji Nagar, Aurangabad, Maharashtra, India

DOI:

https://doi.org/10.18203/2349-3259.ijct20260043

Keywords:

HFRT, CFRT, CCRT, Low dose paclitaxel and carboplatin, Laryngeal and hypopharyngeal carcinoma, HNSCC, RECIST

Abstract

Background: Conventional fractionated radiotherapy (CFRT) with weekly cisplatin is the standard of care for locally advanced laryngeal and hypopharyngeal carcinoma but is often limited by significant toxicity. This study evaluates hypofractionated radiotherapy (HFRT) combined with weekly low-dose paclitaxel and carboplatin as a more tolerable alternative. Objective of the study was to compare the tumor response and toxicity profiles of HFRT plus paclitaxel/carboplatin versus CFRT plus cisplatin.

Methods: Sixty-four patients with stage III–IVB carcinoma were randomized into two arms. Arm 1 received HFRT (63 Gy in 28 fractions) with weekly paclitaxel (30 mg/m²) and carboplatin (AUC 1.5). Arm 2 received CFRT (70 Gy in 35 fractions) with weekly cisplatin (30 mg/m²). Response was assessed via RECIST 1.1; toxicities were graded using RTOG/CTCAE criteria.

Results: At 6 weeks post-treatment, the complete response (CR) rate was 71.9% in arm 1 and 68.8% in arm 2. Arm 1 demonstrated a significantly improved safety profile, with lower rates of grade 3 mucositis (28.1% versus 43.8%) and grade 3 leukopenia (15.6% versus 28.1%). Additionally, grade 2 skin reactions (25% versus 37.5%) and nausea/vomiting (31.3% versus 53.1%) were less frequent in arm 1, leading to higher treatment compliance.

Conclusions: HFRT with weekly low-dose paclitaxel/carboplatin offers non-inferior efficacy and superior tolerability compared to standard CFRT. It is a viable therapeutic strategy for elderly or renal-compromised patients and in resource- constrained settings.

Metrics

Metrics Loading ...

References

Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, et al. Global Cancer Statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2021;71(3):209-49. DOI: https://doi.org/10.3322/caac.21660

Saito E, Kawachi I, Nanri A, Ojima T, Nagahama S, Takashima N, et al. Trends in incidence and mortality rates for cancers of the oral cavity, pharynx, and larynx in Japan, 1993–2015. BMC Cancer. 2022;22:353.

Pignon JP, le Maître A, Maillard E, Boughs J; MACH-NC Collaborative Group. Meta-analysis of chemotherapy in head and neck cancer (MACH-NC): An update on 93 randomised trials and 17,346 patients. Radiotherapy Oncol. 2009;92(1):4-14.

Espeli V, Zucchetta L, Ottaviani D, Mazzarotto R, Tirocchi A, Paoloni F, et al. Nephrotoxicity, ototoxicity, and hematologic toxicity in head and neck cancer patients receiving high-dose cisplatin chemoradiotherapy: A prospective observational study. BMC Cancer. 2020;20:120.

Slevin F, McDowell L, Hanna GG. Hypofractionated radiotherapy in head and neck cancer: Evidence base, practical considerations and future directions. Clin Oncol. 2021;33(2):124-35.

Porceddu SV, Rosser B, Burmeister BH, Jones M, Hickey B, Baumann K, et al. Hypofractionated radiotherapy for the palliation of advanced head and neck cancer in patients unsuitable for curative treatment— “Hypo Trial.” Radiother Oncol. 2007;85(3):456-62. DOI: https://doi.org/10.1016/j.radonc.2007.10.020

Withers HR, Taylor JM, Maciejewski B. The hazard of accelerated tumor clonogen repopulation during radiotherapy. Acta Oncol. 1988;27(2):131-46. DOI: https://doi.org/10.3109/02841868809090333

Agarwala S, Suntharalingam M, Cmelak AJ, Machtay M, Sundaram S, Langer CJ, et al. Concurrent low dose Paclitaxel, Carboplatin, and radiotherapy in advanced head and neck carcinoma: a phase II trial. Int J Radiat Oncol Biol Phys. 2007;68(2):446-53.

Hoek J, Bloemendal KM, Van der Velden L-AA, Van Diessen JNA, Van Werkhoven E, Klop WMC, et al. Nephrotoxicity as a Dose-Limiting Factor in a High-Dose Cisplatin-Based Chemoradiotherapy Regimen for Head and Neck Carcinomas. Cancers. 2016;8(2):21. DOI: https://doi.org/10.3390/cancers8020021

Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, et al. New response evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1). Eur J Cancer. 2009;45(2):228-47. DOI: https://doi.org/10.1016/j.ejca.2008.10.026

Machtay M, Moughan J, Trotti A, Garden AS, Weber RS, Cooper JS, et al. Factors associated with severe late toxicity after concurrent chemoradiation for locally advanced head and neck cancer: an RTOG analysis. J Clin Oncol. 2008;26(21):3582-9. DOI: https://doi.org/10.1200/JCO.2007.14.8841

Agarwal JP, Kumar S, Chaukar DA, D’Cruz AK, Gupta T, Laskar SG, et al. Curative- intent radiotherapy in head and neck squamous cell carcinoma: Analysis of compliance, toxicity and survival. Indian J Cancer. 2012;49(2):159-66.

Suntharalingam M, Haas ML, Conley BA, Egorin MJ, Kies MS, Strome SE, et al. The use of weekly low dose Paclitaxel and Carboplatin as radiosensitizers in the treatment of locally advanced head and neck cancer. Semin Oncol. 2003;30(6 Suppl 18):49-52.

Cmelak AJ, Li S, Goldwasser MA, Murphy B, Cannon M, Pinto H, et al. Phase II trial of chemoradiation with low dose Paclitaxel and Carboplatin for locally advanced squamous cell carcinoma of the head and neck: RTOG 99-14. J Clin Oncol. 2007;25(25):3736-42. DOI: https://doi.org/10.1200/JCO.2007.10.8951

Suntharalingam M, Haas ML, Conley BA, Egorin MJ, Levy S, Sivasailam S, et al. The use of carboplatin and paclitaxel with daily radiotherapy in patients with locally advanced squamous cell carcinomas of the head and neck. Int J Radiat Oncol Biol Phys. 2000;47(1):49-56. DOI: https://doi.org/10.1016/S0360-3016(00)00408-9

van Hagen P, Hulshof MC, van Lanschot JJ, Steyerberg EW, van Berge Henegouwen MI, Wijnhoven BP, et al. Preoperative chemoradiotherapy for esophageal or junctional cancer. N Engl J Med. 2012;366(22):2074-84. DOI: https://doi.org/10.1056/NEJMoa1112088

Spartacus RK, Dana R, Rastogi K, Bhatnagar AR, Daga D, Gupta K. Hypofractionated Radiotherapy for Palliation in Locally Advanced Head and Neck Cancer. Indian J Palliat Care. 2017;23(3):313-6. DOI: https://doi.org/10.4103/IJPC.IJPC_9_17

Roy S, Mallik C, Ghorai S, Hazra A, Majumdar A. Hypofractionated versus conventional radiotherapy with or without chemotherapy in head and neck cancer: a comparative study. Clin Cancer Investig J. 2015;4(2):140–6. DOI: https://doi.org/10.4103/2278-0513.152718

Pignon JP, le Maître A, Maillard E, Bourhis J; MACH-NC Collaborative Group. Meta-analysis of chemotherapy in head and neck cancer (MACH-NC): An update on 93 randomized trials and 17,346 patients. Radiotherapy Oncol. 2009;92(1):4-14. DOI: https://doi.org/10.1016/j.radonc.2009.04.014

Forastiere AA, Goepfert H, Maor M, Pajak TF, Weber R, Morrison W, et al. Concurrent chemotherapy and radiotherapy for organ preservation in advanced laryngeal cancer. N Engl J Med. 2003;349(22):2091-8. DOI: https://doi.org/10.1056/NEJMoa031317

Agarwal JP, Gupta T, Laskar SG, Budrukkar A, Murthy V, Ghosh-Laskar S, et al. Hypofractionated, palliative radiotherapy for advanced head and neck cancer: results from a prospective randomized clinical trial. Head Neck. 2008;30(4):407-12.

Gupta T, Agarwal JP, Ghosh-Laskar S, Parikh PM, D’Cruz AK, Dinshaw KA. Radical radiotherapy with concurrent weekly cisplatin for locally advanced head and neck squamous cell carcinoma: a single-institution experience. Head Neck Oncol. 2009;1:17. DOI: https://doi.org/10.1186/1758-3284-1-17

Mendez LC, Raziee H, Davidson M, Barnes E, Tsang R, Louie AV. Global cancer control: Role of radiotherapy and related infrastructure and workforce in meeting the goal of universal health coverage. Clin Oncol (R Coll Radiol). 2017;29(2):99-102.

Chougule PB, Akhtar MS, Rathore R, Koness J, McRae R, Nigri P, et al. Concurrent chemoradiotherapy with weekly paclitaxel and carboplatin for locally advanced head and neck cancer: Long-term follow-up of a Brown University Oncology Group Phase II Study (HN-53). Head Neck. 2008;30(3):289-96. DOI: https://doi.org/10.1002/hed.20700

Nassif S, Wichmann J, Strube D, Vassis S, Christiansen H, Steinmann D. Cisplatin Versus Carboplatin and Low dose Paclitaxel in Radiochemotherapy for Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma. In Vivo. 2022;36(2):821-32. DOI: https://doi.org/10.21873/invivo.12769

Trotti A, Bellm LA, Epstein JB, Frame D, Fuchs HJ, Gwede CK, et al. Mucositis incidence, severity and associated outcomes in patients with head and neck cancer receiving radiotherapy with or without chemotherapy: a systematic literature review. Radiother Oncol. 2003;66(3):253-62. DOI: https://doi.org/10.1016/S0167-8140(02)00404-8

Dwyer PM, Barton MB, Kumar S, Vinod SK. Benefits and costs of hypofractionated radiotherapy for cancer treatment. Clin Oncol (R Coll Radiol). 2020;32(1):13-20.

Lievens Y, Gospodarowicz M, Grover S, Jaffray D, Rodin D, Torode J, et al. Global impact of radiotherapy in oncology: Saving one million lives by 2035. Radiother Oncol. 2017;125(2):175-7. DOI: https://doi.org/10.1016/j.radonc.2017.10.027

Downloads

Published

2026-01-22

How to Cite

Meshram, D., Shewalkar, B., Patel, J., & Pant, P. (2026). Hypofractionated radiotherapy with weekly paclitaxel and carboplatin versus conventional fractionation radiotherapy with weekly cisplatin in carcinoma of the larynx and hypopharynx for response and toxicity assessment. International Journal of Clinical Trials, 13(1), 23–29. https://doi.org/10.18203/2349-3259.ijct20260043

Issue

Section

Original Research Articles