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Proffered Paper - GI, colorectal

399O - Oxaliplatin plus fluoropyrimidines as adjuvant therapy for colon cancer in elderly patients: A subgroup analysis from TOSCA trial

Date

19 Sep 2020

Session

Proffered Paper - GI, colorectal

Presenters

Sara Lonardi

Citation

Annals of Oncology (2020) 31 (suppl_4): S409-S461. 10.1016/annonc/annonc270

Authors

S. Lonardi1, G. Rosati2, F. Galli3, K.F. Dotti4, M. Ronzoni5, M.G. Zampino6, M. Banzi7, V. Pusceddu8, F. Pasini9, S. Bozzarelli10, N. Pella11, C. Codecà12, V. Montesarchio13, A. Mambrini14, A. De Stefano15, L. Ciuffreda16, S.E. Rebuzzi17, F. Galli3, D. Bilancia18, R. Labianca19

Author affiliations

  • 1 Oncology, IRCCS Istituto Oncologico Veneto, 35128 - Padova/IT
  • 2 Medical Oncology, Azienda Ospedaliera Regionale S. Carlo di Potenza, 85100 - Potenza/IT
  • 3 Statistics Unit, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, 20156 - Milan/IT
  • 4 Medicina Oncologica 1, Fondazione IRCCS INT, 20133 - Milan/IT
  • 5 Oncologia Medica, Ospedale San Raffaele, 20132 - Milan/IT
  • 6 Medical Oncology Department, IEO - Istituto Europeo di Oncologia, 20141 - Milan/IT
  • 7 Oncologia Medica, Azienda Ospedaliera Arcispedale Santa Maria Nuova - IRCCS, 42100 - Reggio Emilia/IT
  • 8 Medical Oncology, University Hospital, 09042 - Cagliari/IT
  • 9 Oncologia Medica, Ospedale Santa Maria della Misericordia, 45100 - Rovigo/IT
  • 10 Oncologia Medica Ed Ematologia, Humanitas Clinical and Research Center-IRCCS, 20089 - Rozzano/IT
  • 11 Medical Oncology, Azienda Ospedaliera Universitaria S. Maria della Misericordia, 33100 - Udine/IT
  • 12 Medical Oncology, Azienda Ospedaliera San Paolo, 20142 - Milan/IT
  • 13 Medical Oncology, Azienda Ospedaliera Dei Colli-Monaldi, 80131 - Napoli/IT
  • 14 Medical Oncology, Azienda USL Toscana Nord Ovest, 54033 - Carrara/IT
  • 15 Medical Oncology, Istituto Nazionale dei Tumori Pascale, 80144 - Napoli/IT
  • 16 Medical Oncology, Ospedale S. Giovanni Battista, 10126 - Torino/IT
  • 17 Medical Oncology 1 Unit, IRCCS AOU San Martino - IST-Istituto Nazionale per la Ricerca sul Cancro, 16132 - Genova/IT
  • 18 Medical Oncology, Ospedale S. Carlo, 85100 - Potenza/IT
  • 19 Medical Oncology, Cancer Center ASST Papa Giovanni XXIII, 24121 - Bergamo/IT
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Resources

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Abstract 399O

Background

Previous studies stating the combination of oxaliplatin and fluoropyrimidines as the standard of care for the adjuvant therapy of stage III colon cancer (CC) patients (pts) obtained non-convergent results and a reduced benefit for those over the age of 70 years.

Methods

We have assessed the impact of age (categorized as < or ≥ 70 years) on relapse free interval (RFI), defined as time from random to relapse or last disease assessment, in stage III CC pts randomized to receive 3 or 6 months of FOLFOX (FULV plus oxaliplatin) or CAPOX (capecitabine plus oxaliplatin) in the Italian, multicenter, phase III, TOSCA study (clinicaltrials.gov NCT0064660).

Results

3,759 pts were enrolled from 130 sites. Overall, 2,360 of them had stage III disease, including 1,667 aged under 70 and 693 aged 70 or over. The elderly had an ECOG performance status (PS) more often equal to 1 (10.5% vs 3.3%, p <0.001), fewer women (40.8% vs 45.1, p=0.057), more T3/T4 tumors (90.9% vs 84.3%, p<0.001), a greater number of poorly differentiated (G3) tumors (28.3% vs 24.2%, p=0.039) and located on the right (40.9% vs 26.6%, p <0.001). No variation for type and treatment arm (p=0.965) was observed. The median follow-up was 62.5 and 60.6 months for the under 70 and the over 70, respectively. In pts over 70, we found a greater proportion of dose reductions (46.7% vs 41.4%, p=0.018), treatment interruptions (26.1% vs 19.3%, p<0.001) and a higher proportion of recurrences (24.2% vs 20.3%, p=0.033). The multivariable analysis of the RFI, corrected for sex, ECOG PS, tumor site, stage, grade, treatment, treatment duration and dose reduction, does not indicate a statistically significant effect of age (HR 1.19, 95% CI 0.98-1.44, p=0.082), although the point estimate is not negligible. Only a stage III high risk CC had a significant impact on RFI (HR [vs low risk] 2.05, 95% CI 1.71-2.46, p<0.001).

Conclusions

Comparing to younger pts, in elderly stage III CC pts treated with an oxaliplatin-based adjuvant therapy, a different treatment tolerability and a potential reduction of benefit was highlighted. Considerations should be made about the patient's general health status, his comorbidities and the management of the expected side effects.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

GISCAD.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.

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