Compliance and toxicity of total neoadjuvant therapy for rectal cancer: A secondary analysis of the OPRA trial Journal Article

   


Authors: Verheij, F. S.; Omer, D. M.; Lin, S. T.; Yuval, J. B.; Thompson, H. M.; Kim, J. K.; Valdivieso, S. C.; Qin, L. X.; Wu, A. J.; Saltz, L. B.; Garcia-Aguilar, J.
Article Title: Compliance and toxicity of total neoadjuvant therapy for rectal cancer: A secondary analysis of the OPRA trial
Abstract: Purpose: Patients with locally advanced rectal cancer treated with total neoadjuvant therapy (TNT) may achieve organ preservation without a compromise to oncologic outcomes. However, reports on patient compliance with TNT and with treatment-related toxicities are limited. Methods and Materials: The OPRA trial assessed organ preservation rates and oncologic outcomes in patients with clinical stage II/III rectal adenocarcinoma randomized to induction chemotherapy followed by chemoradiation (INCT-CRT) or chemoradiation followed by consolidation chemotherapy (CRT-CNCT). Systemic chemotherapy consisted of 8 cycles (16 weeks) of fluorouracil, leucovorin, and oxaliplatin (FOLFOX) or 5 cycles (15 weeks) of capecitabine and oxaliplatin (CAPEOX). Patients received >4500 cGy of radiation with sensitizing capecitabine or fluorouracil. In this report, we compare compliance and treatment-related toxicity in patients receiving INCT-CRT versus CRT-CNCT. Additionally, we evaluate the association of compliance to chemotherapy, compliance to chemoradiation, and toxicity with organ preservation and disease-free survival (DFS). Results: Of the 324 patients randomized, fewer patients started chemoradiation in the INCT-CRT group compared with the CRT-CNCT group (93% vs 98%, P = .03), and fewer patients started systemic chemotherapy in the CRT-CNCT group compared with the INCT-CRT group (94% vs 99%, P = .04). Order of TNT did not affect the ability to complete all intended cycles of FOLFOX (86% INCT-CRT vs 83% CRT-CNCT, P = .60) or CAPEOX (74% INCT-CRT vs 77% CRT-CNCT, P = .80). A total of 97% of INCT and 98% of CRT-CNCT patients received >4500 cGy radiation (P = .93). Sixty-four patients (41%) treated with INCT-CRT and 57 CRT-CNCT patients (34%) experienced a grade 3+ adverse event (P = .30). Compliance and toxicity were not associated with organ preservation or DFS. Conclusions: We identified only minor differences in treatment compliance between patients treated with INCT-CRT and CRT-CNCT. No difference in adverse events was observed between groups. Treatment compliance and toxicity did not correlate with organ preservation rates or DFS. © 2023 Elsevier Inc.
Keywords: adult; cancer survival; controlled study; treatment outcome; major clinical study; neutropenia; fluorouracil; diarrhea; capecitabine; disease free survival; neoadjuvant therapy; chemotherapy; cancer staging; antineoplastic agent; neoplasm staging; infection; multiple cycle treatment; gastrointestinal symptom; randomized controlled trial; antineoplastic combined chemotherapy protocols; radiotherapy dosage; dehydration; radiotherapy; patient monitoring; continuous infusion; pathology; hyperglycemia; cardiovascular disease; folinic acid; patient compliance; suicide; intermethod comparison; organ preservation; sex difference; toxicity; oxaliplatin; rectal neoplasms; rectum tumor; neurologic disease; leucovorin; diseases; hematologic disease; chemoradiotherapy; induction chemotherapy; electrolyte disturbance; enterocolitis; secondary analysis; randomized controlled trial (topic); rectal adenocarcinoma; phase 2 clinical trial (topic); adverse events; multicenter study (topic); procedures; neoadjuvant chemoradiotherapy; consolidation chemotherapy; humans; human; male; female; article; chemo radiations; consolidation chemotherapies
Journal Title: International Journal of Radiation Oncology, Biology, Physics
Volume: 118
Issue: 1
ISSN: 0360-3016
Publisher: Elsevier Inc.  
Date Published: 2024-01-01
Start Page: 115
End Page: 123
Language: English
DOI: 10.1016/j.ijrobp.2023.07.043
PUBMED: 37544412
PROVIDER: scopus
PMCID: PMC11027192
DOI/URL:

https://www.scopus.com/inward/record.uri?eid=2-s2.0-85169836273&doi=10.1016%2fj.ijrobp.2023.07.043&partnerID=40&md5=a5b7343baa413904bfcae3cba7ef2ab7
Notes: The MSK Cancer Center Support Grant (P30 CA008748) is acknowledged in PubMed and PDF -- Corresponding author is MSK author: Julio Garcia-Aguilar -- Source: Scopus
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MSK Authors
  1. Leonard B Saltz
    790 Saltz
  2. Li-Xuan Qin
    190 Qin
  3. Abraham Jing-Ching Wu
    400 Wu
  4. Julio Garcia Aguilar
    347 Garcia Aguilar
  5. Jonathan Benjamin Yuval
    37 Yuval
  6. Hannah Marie Thompson
    44 Thompson
  7. Floris Stefanus Verheij
    36 Verheij
  8. Jin Ki Kim
    31 Kim
  9. Dana Mohamed Rashid Omer
    32 Omer
  10. Sabrina Lin
    24 Lin
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