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Quality of life in a randomized trial comparing two neoadjuvant regimens for locally advanced rectal cancer—INCAGI004

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Abstract

Background

Neoadjuvant chemoradiotherapy (neoCRT) followed by surgery is the standard of care for locally advanced rectal cancer (LARC), but the emergence of different drug regimens may result in different response rates. Good clinical response translates into greater sphincter preservation, but quality of life (QOL) may be impaired after treatment due to chemoradiotherapy and surgical side effects.

Objective

To prospectively evaluate the impact of clinical response and surgical resection on QOL in a randomized trial comparing two different neoCRT regimens.

Methods

Stage II and III rectal cancer patients were randomized to receive neoCRT with either capecitabine (group 1) or 5-Fu and leucovorin (group 2) concomitant to long-course radiotherapy. Clinical downstaging was accessed using MRI 6–8 weeks after treatment. EORTCs QLQ-C30 and CR38 were applied before treatment (T0), after neoCRT (T1), after rectal resection (T2), early after adjuvant chemotherapy (T3), and 1 year after the end of treatment or stoma closure (T4). The Wexner scale was used for fecal incontinence evaluation at T4. A C30SummaryScore (Geisinger and cols.) was calculated to compare QOL results.

Results

Thirty-two patients were assigned to group 1 and 31 to group 2. Clinical downstaging occurred in 70.0% of group 1 and 53.3% of group 2 (p = 0.288), and sphincter preservation was 83.3% in group 1 and 80.0% in group 2 (p = 0.111). No significant difference in QOL was detected when comparing the two treatment groups after neoCRT using QLQ-C30. However, the CR38 module detected differences in micturition problems (15.3 points), gastrointestinal problems (15.3 points), defecation problems (11.8 points), and sexual satisfaction (13.3 points) favoring the capecitabine group. C30SummaryScore detected significant improvement comparing T0 to T1 and deterioration comparing T1 to T2 (p = 0.025). The mean Wexner scale score was 9.2, and a high score correlated with symptoms of diarrhea and defecation problems at T4.

Conclusions

QOL was equivalent between groups after neoCRT except for micturition problems, gastrointestinal problems, defecation problems, and sexual satisfaction favoring the capecitabine arm after. The overall QOL using the C30SummaryScore was improved after neoCRT, but decreased following rectal resection, returning to basal levels at late evaluation. Fecal incontinence was high after sphincter preservation.

Trial registration

ClinicalTrials.gov Identifier: NCT03428529.

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Data availability

The datasets during and/or analyzed during the current study are publicly available at Mendeley dataset as: Araujo, Rodrigo Otavio (2021), “INCAGI004”, Mendeley Data, V1, https://doi.org/10.17632/75vdm7phv9.1. The datasets during and/or analyzed during the current study are available from the corresponding author on reasonable request.

Abbreviations

5-Fu/Lv:

5-Fluorouracil and leucovorin

AJCC:

American Joint Commission on Cancer

APR:

Abdominoperineal resection

AV:

Anal verge

C30SumScore:

C30 Summary Score

CT:

Computer tomography

CTCAE:

Common Terminology for Adverse Events

EORTC:

European Organization for Research and Treatment of Cancer

EUS:

Endorectal ultrasound

INCA:

Instituto Nacional de Cancer (National Cancer Institute of Brazil)

ISR:

Intersphincteric resection

LAR:

Low anterior resection

LARC:

Locally advanced rectal cancer

LARS:

Low anterior resection syndrome

MRI:

Magnetic resonance imaging

neoCRT:

Neoadjuvant chemoradiotherapy

QLQ-C30:

Quality of Life Questionnaire C30

QOL:

Quality of life

SD:

Standard deviation

TME:

Total mesorectal excision

USA:

United States of America

References

  1. Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA: A Cancer Journal for Clinicians [Internet]. 2018 [cited 2020 Dec 5];68(6):394–424. Available from: https://pubmed.ncbi.nlm.nih.gov/30207593/

  2. Instituto Nacional de Câncer José Alencar Gomes da Silva. Estimativa 2018: incidência de câncer no Brasil. Rio de Janeiro, Brazil: INCA; 2017. 128 p

  3. Amin MB, Edge S, Greene F, Byrd DR, Brookland RK, Washington MK, Gershenwald JE, Compton CC, Hess KR et al (2017) AJCC Cancer Staging Manual (8th edition), 8th edn. Springer International Publishing, American Joint Commission on Cancer

    Book  Google Scholar 

  4. Sauer R, Becker H, Hohenberger W, Rödel C, Wittekind C, Fietkau R et al (2004) Preoperative versus postoperative chemoradiotherapy for rectal cancer. N Engl J Med 351(17):1731–40. https://doi.org/10.1056/NEJMoa040694

    Article  CAS  PubMed  Google Scholar 

  5. Hofheinz R-D, Wenz F, Post S, Matzdorff A, Laechelt S, Hartmann JT et al (2012) Chemoradiotherapy with capecitabine versus fluorouracil for locally advanced rectal cancer: a randomised, multicentre, non-inferiority, phase 3 trial. Lancet Oncol 13(6):579–588

    Article  CAS  Google Scholar 

  6. Kim JS, Kim JS, Cho MJ, Yoon WH, Song KS (2006) Comparison of the efficacy of oral capecitabine versus bolus 5-FU in preoperative radiotherapy of locally advanced rectal cancer. J Korean Med Sci 21(1):52–57

    Article  CAS  Google Scholar 

  7. Saif MW, Hashmi S, Zelterman D, Almhanna K, Kim R (2008) Capecitabine vs continuous infusion 5-FU in neoadjuvant treatment of rectal cancer. A retrospective review. Int J Color Dis 23(2):139–45

    Article  CAS  Google Scholar 

  8. Allegra CJ, Yothers G, O’Connell MJ, Beart RW, Wozniak TF, Pitot HC et al (2015) Neoadjuvant 5-FU or capecitabine plus radiation with or without oxaliplatin in rectal cancer patients: a phase III randomized clinical trial. J Natl Cancer Inst 107(11)

  9. O’Connell MJ, Colangelo LH, Beart RW, Petrelli NJ, Allegra CJ, Sharif S et al (2014) Capecitabine and oxaliplatin in the preoperative multimodality treatment of rectal cancer: surgical end points from National Surgical Adjuvant Breast and Bowel Project trial R-04. J Clin Oncol 32(18):1927–1934

    Article  Google Scholar 

  10. Sawada N, Ishikawa T, Sekiguchi F, Tanaka Y, Ishitsuka H (1999) X-Ray Irradiation induces thymidine phosphorylase and enhances the efficacy of capecitabine (Xeloda) in human cancer xenografts. Clin Cancer Res 5(10)

  11. Schüller J, Cassidy J, Dumont E, Roos B, Durston S, Banken L et al (2000) Preferential activation of capecitabine in tumor following oral administration to colorectal cancer patients. Cancer Chemother Pharmacol 45(4):291–297

    Article  Google Scholar 

  12. Twelves C, Boyer M, Findlay M, Cassidy J, Weitzel C, Barker C et al (2001) Capecitabine (Xeloda) improves medical resource use compared with 5-fluorouracil plus leucovorin in a phase III trial conducted in patients with advanced colorectal carcinoma. Eur J Cancer (Oxford, English: 1990) 37(5):597–604

    Article  CAS  Google Scholar 

  13. Heald RJ, Moran BJ, Ryall RDH, Sexton R, MacFarlane JK. Rectal Cancer: The Basingstoke experience of total mesorectal excision, 1978–1997. Arch Surg [Internet]. 1998 [cited 2021 Mar 20];133(8):894–9. Available from: https://pubmed.ncbi.nlm.nih.gov/9711965/

  14. Rödel C, Graeven U, Fietkau R, Hohenberger W, Hothorn T, Arnold D, et al. Oxaliplatin added to fluorouracil-based preoperative chemoradiotherapy and postoperative chemotherapy of locally advanced rectal cancer (the German CAO/ARO/AIO-04 study): Final results of the multicentre, open-label, randomised, phase 3 trial. Lancet Oncol [Internet]. 2015 [cited 2021 Mar 20];16(8):979–89. Available from: https://linkinghub.elsevier.com/retrieve/pii/S147020451500159X

  15. Miles WE (1931) The present position of the radical abdomino-perineal operation for cancer of the rectum in regard to mortality and post-operative recurrence. Proc R Soc Med 24(7):989–991

    CAS  PubMed  PubMed Central  Google Scholar 

  16. Rullier E, Denost Q, Vendrely V, Rullier A, Laurent C. Low rectal cancer. Diseases of the Colon & Rectum [Internet]. 2013 [cited 2021 Mar 20];56(5):560–7. Available from: https://journals.lww.com/00003453-201305000-00004

  17. Engel J, Kerr J, Schlesinger-Raab A, Eckel R, Sauer H, Hölzel D. Quality of life in rectal cancer patients. Ann Surg [Internet]. 2003 [cited 2021 Mar 20];238(2):203–13. Available from: /pmc/articles/PMC1422675/

  18. Havenga K, Enker WE, McDermott K, Cohen AM, Minsky BD, Guillem J (1996) Male and female sexual and urinary function after total mesorectal excision with autonomic nerve preservation for carcinoma of the rectum. J Am Coll Surg 182(6):495–502

    CAS  PubMed  Google Scholar 

  19. Ridolfi TJ, Berger N, Ludwig KA. Low anterior resection syndrome: current management and future directions. 2016.

  20. Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, et al. The European organization for research and treatment of cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst [Internet]. 1993 [cited 2021 Mar 20];85(5):365–76. Available from: https://pubmed.ncbi.nlm.nih.gov/8433390/

  21. Sprangers MA, Velde A, Aaronson NK (1999) The construction and testing of the EORTC colorectal cancer-specific quality of life questionnaire module (QLQ-CR38). European Organization for Research and Treatment of Cancer Study Group on Quality of Life. Eur J Cancer (Oxford, English: 1990) 35(2):238–47

    Article  CAS  Google Scholar 

  22. Whistance RN, Conroy T, Chie W, Costantini A, Sezer O, Koller M et al (2009) Clinical and psychometric validation of the EORTC QLQ-CR29 questionnaire module to assess health-related quality of life in patients with colorectal cancer. Eur J Cancer (Oxford, England: 1990) 45(17):3017–26

    Article  CAS  Google Scholar 

  23. Maslyankov S, Penchev D, Todorov G, Vladov N (2015) A meta-analysis of quality of life, estimated by questionnaires of the European Organization for Research and Treatment of Cancer (EORTC) after rectal cancer surgery. Chirurgia (Bucharest, Romania: 1990) 110(4):356–61

    CAS  Google Scholar 

  24. Grumann MM, Noack EM, Hoffmann IA, Schlag PM. Comparison of quality of life in patients undergoing abdominoperineal extirpation or anterior resection for rectal cancer. 2001.

  25. Phillips R, Gandhi M, Cheung YB, Findlay MP, Win KM, Hai HH et al (2015) Summary scores captured changes in subjects’ QoL as measured by the multiple scales of the EORTC QLQ-C30. J Clin Epidemiol 68(8):895–902

    Article  Google Scholar 

  26. Giesinger JM, Kieffer JM, Fayers PM, Groenvold M, Petersen MA, Scott NW et al (2016) Replication and validation of higher order models demonstrated that a summary score for the EORTC QLQ-C30 is robust. J Clin Epidemiol 1(69):79–88

    Article  Google Scholar 

  27. Pompili C, Koller M, Velikova G, Franks K, Absolom K, Callister M et al (2018) EORTC QLQ-C30 summary score reliably detects changes in QoL three months after anatomic lung resection for Non-Small Cell Lung Cancer (NSCLC). Lung Cancer (Amsterdam, Netherlands) 123:149–154

    Article  Google Scholar 

  28. Husson O, Rooij BH, Kieffer J, Oerlemans S, Mols F, Aaronson NK et al (2020) The EORTC QLQ-C30 summary score as prognostic factor for survival of patients with cancer in the “real-world”: results from the population-based PROFILES Registry. Oncologist 25(4)

  29. AJCC Cancer Staging Handbook - From the AJCC Cancer Staging Manual | Stephen Edge | Springer [Internet]. [cited 2020 Dec 7]. Available from: https://www.springer.com/gp/book/9780387884424

  30. Paiva CE, Carneseca EC, Barroso EM, de Camargos MG, Alfano ACC, Rugno FC et al (2014) Further evaluation of the EORTC QLQ-C30 psychometric properties in a large Brazilian cancer patient cohort as a function of their educational status. Support Care Cancer 22(8):2151–2160

    PubMed  Google Scholar 

  31. Souza R, Barros C, Souza R, Cesar M, Rosa D, Bin F et al (2005) Avaliação da qualidade de vida de doentes de carcinoma retal, submetidos à ressecção com preservação esfincteriana ou à amputação abdominoperineal. Rev Bras Coloproct 25(3):235–240

    Google Scholar 

  32. Rusavy Z, Jansova M, Kalis V (2014) Anal incontinence severity assessment tools used worldwide. Int J Gynecol Obstet 126(2):146–50. https://doi.org/10.1016/j.ijgo.2014.02.025

    Article  Google Scholar 

  33. D’amico F, Wexner SD, Vaizey CJ, Elia Gouynou C, Danese S, Peyrin-Biroulet L. Tools for fecal incontinence assessment: lessons for inflammatory bowel disease trials based on a systematic review.

  34. Fonseca AM, Meinberg MF, Lucas DV, Monteiro MV, Figueiredo EM, Fonseca L et al (2016) Cultural adaptation and validation of the Wexner scale in patients with anal incontinence in a Brazilian population. Int Urogynecol J 27(6):959–963

    Article  Google Scholar 

  35. Osoba D (1999) Interpreting the meaningfulness of changes in health-related quality of life scores: lessons from studies in adults. Int J Cancer Suppl 12

  36. Hathiramani S, Pettengell R, Moir H, Younis A. Relaxation versus exercise for improved quality of life in lymphoma survivors-a randomised controlled trial. https://doi.org/10.1007/s11764-020-00941-4

  37. Vos JAM, Duineveld LAM, Wieldraaijer T, Wind J, Busschers WB, Sert E et al (2021) Effect of general practitioner-led versus surgeon-led colon cancer survivorship care, with or without eHealth support, on quality of life (I CARE): an interim analysis of 1-year results of a randomised, controlled trial. Lancet Oncol 22(8):1175–1187

    Article  Google Scholar 

  38. Lee KA, Dunne M, Small C, Kelly PJ, Mcardle O, O’sullivan J, et al. Acta Oncologica (ICORG 05–03): prospective randomized non-inferiority phase III trial comparing two radiation schedules in malignant spinal cord compression (not proceeding with surgical decompression); the quality of life analysis (ICORG 05–03): prospective randomized non-inferiority phase III trial comparing two radiation schedules in malignant spinal cord compression (not proceeding with surgical decompression); the quality of life analysis. 2018; Available from: https://www.tandfonline.com/action/journalInformation?journalCode=ionc20

  39. Nesbakken A, Nygaard K, Lunde OC (2000) Outcome and late functional results after anastomotic leakage following mesorectal excision for rectal cancer [Internet]. Br J Surg 88. Available from: www.bjs.co.uk

  40. Anthony T, Long J, Hynan LS, Sarosi GA, Nwariaku F, Huth J et al (2003) Surgical complications exert a lasting effect on disease-specific health-related quality of life for patients with colorectal cancer. Surgery 134(2):119–125

    Article  Google Scholar 

  41. Brown SR, Mathew R, Keding A, Marshall HC, Brown JM, Jayne DG (2014) The impact of postoperative complications on long-term quality of life after curative colorectal cancer surgery. Ann Surg [Internet]. [cited 2022 Feb 23];259(5):916–23. Available from: https://journals.lww.com/annalsofsurgery/Fulltext/2014/05000/The_Impact_of_Postoperative_Complications_on.13.aspx

  42. Lin JK, Tan CHE, Yang MC (2015) Comparing the effectiveness of capecitabine versus 5-fluorouracil/leucovorin therapy for elderly Taiwanese stage III colorectal cancer patients based on quality-of-life measures (QLQ-C30 and QLQ-CR38) and a new cost assessment tool. Health and Quality of Life Outcomes [Internet]. [cited 2021 Mar 27];13(1):61. Available from: http://hqlo.biomedcentral.com/articles/10.1186/s12955-015-0261-1

  43. Seymour MT, Thompson LC, Wasan HS, Middleton G, Brewster AE, Shepherd SF et al (2011) Chemotherapy options in elderly and frail patients with metastatic colorectal cancer (MRC FOCUS2): an open-label, randomised factorial trial. Lancet (London, England) 377(9779):1749–1759

    Article  CAS  Google Scholar 

  44. Conroy T, Hebbar M, Bennouna J, Ducreux M, Ychou M, Llédo G et al (2010) Quality-of-life findings from a randomised phase-III study of XELOX vs FOLFOX-6 in metastatic colorectal cancer. Br J Cancer 102(1):59–67

    Article  CAS  Google Scholar 

  45. Bonjer HJ, Deijen CL, Abis GA, Cuesta MA, van der Pas MHGM, de Lange-de Klerk ESM et al (2015) A randomized trial of laparoscopic versus open surgery for rectal cancer. N Engl J Med 372(14):1324–1332

    Article  CAS  Google Scholar 

  46. Rapkin BD, Schwartz CE (2019) Advancing quality-of-life research by deepening our understanding of response shift: a unifying theory of appraisal. Vol. 28, Quality of Life Research. Springer International Publishing; p. 2623–30

  47. Schwartz CE, Sprangers MAG (1999) Methodological approaches for assessing response shift in longitudinal health-related quality-of-life research. In: Social Science and Medicine [Internet]. Soc Sci Med [cited 2021 Mar 27]. p. 1531–48. Available from: https://pubmed.ncbi.nlm.nih.gov/10400255/

  48. van der Valk MJM, Hilling DE, Meershoek-Klein Kranenbarg E, Peeters KCMJ, Kapiteijn E, Tsonaka R et al (2019) Quality of life after curative resection for rectal cancer in patients treated with adjuvant chemotherapy compared with observation: results of the randomized phase III SCRIPT Trial. Dis Colon Rectum 62(6):711–720

    Article  Google Scholar 

  49. Sturiale A, Martellucci J, Zurli L, Vaccaro C, Brusciano L, Limongelli P et al (2017) Long-term functional follow-up after anterior rectal resection for cancer. Int J Color Dis [Internet]. [cited 2021 Mar 27];32(1):83–8. Available from: https://pubmed.ncbi.nlm.nih.gov/27695976/

  50. Pieniowski EHA, Palmer GJ, Juul T, Lagergren P, Johar A, Emmertsen KJ et al (2019) Low anterior resection syndrome and quality of life after sphincter-sparing rectal cancer surgery: a long-term longitudinal follow-up. Diseases of the Colon and Rectum [Internet]. [cited 2021 Mar 27];62(1):14–20. Available from: https://journals.lww.com/00003453-201901000-00005

  51. Kasper B (2020) The EORTC QLQ-C30 summary score as a prognostic factor for survival of patients with cancer: a commentary. Available from: www.TheOncologist.com

  52. Husson O, de Rooij BH, Kieffer J, Oerlemans S, Mols F, Aaronson NK et al (2019) The EORTC QLQ-C30 summary score as prognostic factor for survival of patients with cancer in the “real-world”: results from the population-based PROFILES Registry

  53. Arraras JI, Suárez J, Arias-de-la-Vega F, Vera R, Ibáñez B, Asin G et al (2013) Quality of life assessment by applying EORTC questionnaires to rectal cancer patients after surgery and neoadjuvant and adjuvant treatment. Revista espanola de enfermedades digestivas 105(5):255–261

    Article  Google Scholar 

  54. Dumont F, Ayadi M, Goéré D, Honoré C, Elias D (2013) Comparison of fecal continence and quality of life between intersphincteric resection and abdominoperineal resection plus perineal colostomy for ultra-low rectal cancer. J Surg Oncol 108(4):225–229

    Article  CAS  Google Scholar 

  55. Konanz J, Herrle F, Weiss C, Post S, Kienle P (2013) Quality of life of patients after low anterior, intersphincteric, and abdominoperineal resection for rectal cancer–a matched-pair analysis. Int J Colorectal Dis 28(5):679–688

    Article  Google Scholar 

  56. Kasparek MS, Hassan I, Cima RR, Larson DR, Gullerud RE, Wolff BG (2011) Quality of life after coloanal anastomosis and abdominoperineal resection for distal rectal cancers: sphincter preservation vs quality of life. Color Dis 13(8):872–877

    Article  CAS  Google Scholar 

  57. Araujo ROC, Valadão M, Borges D, Linhares E, de Jesus JP, Ferreira CG et al (2015) Nonoperative management of rectal cancer after chemoradiation opposed to resection after complete clinical response. A comparative study. Eur J Surg Oncol 41(11)

  58. Chadi SA, Malcomson L, Ensor J, Riley RD, Vaccaro CA, Rossi GL et al (2018) Factors affecting local regrowth after watch and wait for patients with a clinical complete response following chemoradiotherapy in rectal cancer (InterCoRe consortium): an individual participant data meta-analysis. Lancet Gastroenterol Hepatol 3(12)

  59. Kamiya T, Uehara K, Nakayama G, Ishigure K, Kobayashi S, Hiramatsu K et al (2016) Early results of multicenter phase II trial of perioperative oxaliplatin and capecitabine without radiotherapy for high-risk rectal cancer: CORONA I study. European Journal of Surgical Oncology [Internet]. [cited 2021 Mar 20];42(6):829–35. Available from: https://pubmed.ncbi.nlm.nih.gov/26968228/

  60. Hasegawa S, Goto S, Matsumoto T, Hida K, Kawada K, Matsusue R et al (2017) A multicenter phase 2 study on the feasibility and efficacy of neoadjuvant chemotherapy without radiotherapy for locally advanced rectal cancer. Annals of Surgical Oncology [Internet]. [cited 2021 Mar 19];24(12):3587–95. Available from: https://pubmed.ncbi.nlm.nih.gov/28685354/

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Acknowledgements

We would like to thank all the supporting team of the mentioned Division, especially Dr. Andreia Cristina de Melo, Isabelle Small, Giovana Kovalesky, Alexandre de Souza Fonseca, Cecilia Ferreira da Silva, and all the staff involved in the protocol from the Radiotherapy Department. We would like to thank Professor Marcelo Nolla Pires from Saddleback University at California, for the additional review and editing.

Funding

The present study was totally supported by the Division of Clinical Research and Technological Development of the National Cancer Institute of Brazil, subordinated to the Ministry of Health of Brazil.

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Authors and Affiliations

  1. Department of Abdominal and Pelvic Surgery, INCA, Rio de Janeiro, Brazil

    Rodrigo Otavio Araujo, Marcus Valadão & Eduardo Linhares

  2. Instituto COI de Educação e Pesquisa, Rio de Janeiro, Brazil

    Fernando Meton Vieira & Ana Paula Victorino

  3. Department of Radiology, INCA, Rio de Janeiro, Brazil

    Claudia Torres

  4. Department of Pathology, INCA, Rio de Janeiro, Brazil

    Ivanir Martins

  5. Department of Digestive Endoscopy, INCA, Rio de Janeiro, Brazil

    Simone Guaraldi

  6. Oncoclinicas Institute for Research and Education, Rio de Janeiro, Brazil

    Carlos Gil Ferreira

  7. Division of Clinical Research and Technological Development, INCA, Rio de Janeiro, Brazil

    Luiz Claudio Thuler

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  1. Rodrigo Otavio Araujo
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Contributions

All the authors made substantial contributions to the manuscript as follows:

Study concepts: Carlos Gil Ferreira and Eduardo Linhares. Study design: Fernando Meton Vieira, Rodrigo Otavio de Castro Araujo, Ana Paula Ornellas. Data acquisition: Rodrigo Otavio de Castro Araujo, Simone Guaraldi and Claudia Carrada. Quality control of data and algorithms: Ana Paula Ornellas, Ivanir Martins, Claudia Carrada. Data analysis and interpretation: Rodrigo Otavio de Castro Araujo e Luiz Claudio Santos Thuler. Statistical analysis: Rodrigo Otavio de Castro Araujo e Luiz Claudio Santos Thuler. Manuscript preparation: Rodrigo Otavio de Castro Araujo. Manuscript editing: Marcus Vinicius Valadão and Simone Guaraldi. Manuscript review: all the authors above.

Corresponding author

Correspondence to Rodrigo Otavio Araujo.

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Ethics approval and consent to participate

This was a prospective study approved by the Ethics Committee of National Cancer Institute of Brazil (INCA) in 2010 under register number 83/10 (NCT03428529). All patients voluntarily agreed to participate after informed consent.

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All authors declare that they consented to submit the paper.

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The authors declare no competing interests.

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Araujo, R.O., Vieira, F.M., Victorino, A.P. et al. Quality of life in a randomized trial comparing two neoadjuvant regimens for locally advanced rectal cancer—INCAGI004. Support Care Cancer 30, 6557–6572 (2022). https://doi.org/10.1007/s00520-022-07059-6

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