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Randomized Controlled Trial of Neoadjuvant Short-Course Radiotherapy Followed by Consolidation Chemotherapy Versus Long-Course Chemoradiotherapy in Locally Advanced Rectal Cancer: Comparison of Overall Response Rates

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Abstract

Background

Management of locally advanced rectal cancer (LARC) is evolving with current emphasis on the addition of chemotherapy to short course radiotherapy (SCRT). We primarily aimed to analyse the difference in overall response rates between SCRT with sequential chemotherapy and standard long-course chemoradiotherapy (LCCRT)in LARC.

Methods

After randomization, patients in arm A received 45 Gy in 25 fractions over 5 weeks with concurrent capecitabine while patients in arm B received 25 Gy in 5 fractions over 1 week followed by 3 cycles of CAPOX (capecitabine and oxaliplatin) chemotherapy. Clinical and radiological response assessment was made after the completion of neoadjuvant treatment, a week prior to surgery. Adjuvant chemotherapy was added to complete 6 months of peri-operative chemotherapy. Surgery was performed between 8 and 10 weeks of completion of radiation treatment in both arms.

Results

Of the 33 patients recruited in this study between February 2020 to July 2021, 17 patients were randomized to arm A and 16 to arm B. The rates of complete tumour regression were 23.1% in arm A versus 35.7% in arm B (p-value = 0.683). Pathological complete response (pCR) rate was 20% arm A versus 30% in arm B (0.446). A higher number of patients in arm B experienced grade 3 diarrhoea, whereas acute skin toxicity was seen only in arm A. SCRT had fewer treatment interruptions compared to LCCRT.

Conclusions

SCRT followed by three cycles of CAPOX chemotherapy in the neoadjuvant setting is comparable to LCCRT in terms of tumour response. This may be a better alternative regimen with fewer treatment interruptions in a resource-limited setting.

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Authors and Affiliations

  1. Department of Radiation Oncology, Dr BRA Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi, 110029, India

    Adila Amariyil & Sushmita Pathy

  2. Department of Medical Oncology, All India Institute of Medical Sciences, New Delhi, India

    Atul Sharma & Raja Pramanik

  3. Department of Surgical Oncology, All India Institute of Medical Sciences, New Delhi, India

    Sunil Kumar & Sandeep Bhoriwal

  4. Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, India

    R. M. Pandey

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  1. Adila Amariyil
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  4. Sunil Kumar
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Contributions

Dr Sushmita Pathy (SP): conception and design of the work, data analysis and interpretation, drafting the article, critical revision of the article, and final approval of version to be published. Dr Adila Amariyil (AA): patient recruitment and treatment, data collection, data analysis and interpretation, and drafting the article. Dr Atul Sharma (AS): critical revision of the article and final approval of the version to be published. Dr Sunil Kumar (SK): critical revision of the article and final approval of the version to be published. Dr Raja Pramanik (RP): critical revision of the article and final approval of the version to be published. Dr Sandeep Bhoriwal (SB): critical revision of the article and final approval of the version to be published. Dr R M Pandey (RM): data analysis, critical revision of the article, and final approval of the version to be published.

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Correspondence to Sushmita Pathy.

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Amariyil, A., Pathy, S., Sharma, A. et al. Randomized Controlled Trial of Neoadjuvant Short-Course Radiotherapy Followed by Consolidation Chemotherapy Versus Long-Course Chemoradiotherapy in Locally Advanced Rectal Cancer: Comparison of Overall Response Rates. J Gastrointest Canc 55, 373–382 (2024). https://doi.org/10.1007/s12029-023-00966-9

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