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Clinical Trial
. 2025 Jul;10(7):105329.
doi: 10.1016/j.esmoop.2025.105329. Epub 2025 Jun 19.

Impact of age and sex on the efficacy and safety of ramucirumab plus paclitaxel as switch maintenance versus continuation of first-line oxaliplatin-based chemotherapy: a subgroup analysis of the ARMANI phase III trial

R Fazio  1 , G Randon  1 , F Bergamo  2 , F Palermo  1 , S Tamberi  3 , E Giommoni  4 , S Di Donato  5 , L Fornaro  6 , O Brunetti  7 , F De Vita  8 , M Valgiusti  9 , S M Gobba  10 , A Spallanzani  11 , S Murgioni  2 , V Bethaz  12 , A Strippoli  13 , T P Latiano  14 , G G Cardellino  15 , C Ceccon  16 , A Raimondi  1 , M Prisciandaro  1 , C C Pircher  1 , M Ambrosini  1 , P Manca  1 , M Fassan  17 , M Di Bartolomeo  1 , M Di Maio  18 , F Pietrantonio  19
Affiliations
Clinical Trial

Impact of age and sex on the efficacy and safety of ramucirumab plus paclitaxel as switch maintenance versus continuation of first-line oxaliplatin-based chemotherapy: a subgroup analysis of the ARMANI phase III trial

R Fazio et al. ESMO Open. 2025 Jul.

Abstract

Background: There is a growing interest in optimizing the therapeutic management of older cancer patients as well as understanding the sex-specific differences in terms of efficacy and safety of cancer treatments. However, limited data are available on the initial therapy of patients with advanced gastro-oesophageal cancer.

Materials and methods: The ARMANI phase III trial showed progression-free survival (PFS) and overall survival (OS) benefit with paclitaxel plus ramucirumab switch maintenance (arm A) versus the continuation of first-line oxaliplatin and fluoropyrimidine (arm B) in patients with advanced human epidermal growth factor receptor 2-negative gastric or gastro-oesophageal junction cancer. We conducted a subgroup analysis aimed at assessing the differences in efficacy, safety and quality of life (QoL) according to age (<70 versus ≥70 years) and sex.

Results: No significant differences in terms of PFS (P = 0.757), OS (P = 0.588) and overall response rates (ORRs) (P = 0.238) were observed between older and younger patients. No significant differences in PFS (P = 0.646), OS (P = 0.858) and ORRs (P = 0.649) were observed between females and males. The effect of treatment arm on survival outcomes was similar across age (P = 0.094) and sex groups (P = 0.469). Looking at specific adverse events, peripheral neuropathy occurred more frequently in younger patients (P = 0.020), anaemia in older patients (P = 0.044) and hand-foot syndrome in women (P = 0.021). Older patients were less likely to receive a post-discontinuation treatment (P = 0.010), especially in arm B (P = 0.026). The impact on QoL was better in arm A, irrespective of age and sex.

Conclusion: The ARMANI trial supported the benefit of the investigated switch maintenance strategy irrespective of age and sex.

Keywords: age; gastric cancer; paclitaxel; ramucirumab; sex; switch maintenance.

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Figures

Figure 1
Figure 1
Survivalanalysis according to age. Kaplan–Meier curves for progression-free survival (PFS) and overall survival (OS) in patients stratified according to (A, B) age (<70 and ≥70 years) and (C, D) age and treatment arm (<70 years arm A, <70 years arm B, ≥70 years arm A and ≥70 years arm B). CI, confidence interval; HR, hazard ratio.
Figure 2
Figure 2
Survival analysis according to sex. Kaplan–Meier curves for progression-free survival (PFS) and overall survival (OS) in patients stratified according to (A, B) sex (female and male) and (C, D) sex and treatment arm (female arm A, female arm B, male arm A and male arm B). CI, confidence interval; HR, hazard ratio.
Figure 3
Figure 3
Quality of life analysis according to age and sex. Mean changes in global quality of life from baseline according to age (A) and sex (B).
See this image and copyright information in PMC

References

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