Abstract | Background: Patients and methods: We carried out a post hoc analysis of the CAO/ARO/AIO-04 phase III trial evaluating primary and secondary end points according to age. Patient and tumor characteristics, NCI CTC adverse events grades 3-4 (version 3.0), dose intensities as well as survival and recurrence data were analyzed in three specified age groups (<60, 60-70, and ≥70 years). The influence of age as a continuous variable on DFS was modeled using a subpopulation treatment effect pattern plot (STEPP) analysis. Results: A total of 1232 patients were assessable. With the exception of Eastern Cooperative Oncology Group status (P < 0.001), no differences in patient and tumor characteristics were noticed between age groups. Likewise, toxicity pattern, dose intensities of CRT and surgical results were similar in all age groups. After a median follow-up of 50 months, in patients aged <60 years a significant benefit of adding oxaliplatin to 5-FU-based CRT and adjuvant chemotherapy was observed for local (P = 0.013) and systemic recurrences (P = 0.023), DFS (P = 0.011), and even overall survival (OS; P = 0.044). The STEPP analysis revealed improved hazard ratios for DFS in patients aged 40-70 years compared with elderly patients treated with oxaliplatin. Conclusion: The addition of oxaliplatin significantly improved DFS and OS in younger patients aged <60 years with advanced rectal cancer. Patients aged ≥70 years had no benefit. Clinical Trials Number: NCT00349076.
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Authors | R-D Hofheinz, D Arnold, E Fokas, M Kaufmann, T Hothorn, G Folprecht, R Fietkau, W Hohenberger, M Ghadimi, T Liersch, G G Grabenbauer, R Sauer, C Rödel, U Graeven, German Rectal Cancer Study Group |
Journal | Annals of oncology : official journal of the European Society for Medical Oncology
(Ann Oncol)
Vol. 29
Issue 8
Pg. 1793-1799
(08 01 2018)
ISSN: 1569-8041 [Electronic] England |
PMID | 29873684
(Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
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Topics |
- Age Factors
- Aged
- Antineoplastic Combined Chemotherapy Protocols
(therapeutic use)
- Chemoradiotherapy
(adverse effects, methods)
- Chemotherapy, Adjuvant
(adverse effects, methods)
- Disease-Free Survival
- Female
- Fluorouracil
(therapeutic use)
- Humans
- Male
- Middle Aged
- Neoadjuvant Therapy
(methods)
- Neoplasm Recurrence, Local
(epidemiology, parasitology, prevention & control)
- Oxaliplatin
(therapeutic use)
- Proctectomy
- Rectal Neoplasms
(mortality, pathology, therapy)
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