European journal of cancer (Oxford, England : 1990) · 2025
Patient-reported outcomes with paclitaxel and ramucirumab switch maintenance in advanced gastroesophageal cancer: A secondary endpoint of the ARMANI phase 3 trial.
СтатьяКлиническое исследование III фазыРандомизированное исследованиеМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Cristarella Eleonora, Ambrosini Margherita, Di Maio Massimo, Lonardi Sara, De Vita Ferdinando, Di Donato Samantha, Giommoni Elisa, Spallanzani Andrea, Bittoni Alessandro, Chini Claudio, Strippoli Antonia, Latiano Tiziana Pia, Brunetti Oronzo, Tamberi Stefano, Cardellino Giovanni Gerardo, Spada Daniele, Fornaro Lorenzo, Alessandrini Sara, Pietrantonio Filippo, Randon Giovanni
Аннотация
BACKGROUND: In the ARMANI trial, switch maintenance with paclitaxel plus ramucirumab improved progression-free survival and overall survival versus continuation of oxaliplatin-based chemotherapy in patients with HER2-negative advanced gastric or gastroesophageal junction cancer. Here, we report the health-related quality of life (HRQOL) outcomes.
METHODS: ARMANI was a multicenter, randomized, open-label phase 3 trial. Patients achieving disease control after 3 months of FOLFOX or CAPOX were randomized to paclitaxel plus ramucirumab (arm A) or continued FOLFOX/CAPOX (arm B). HRQOL was assessed using EORTC QLQ-C30, QLQ-OG25, and EQ-5D-5L at baseline and every 8 weeks until progressive disease (PD). Endpoints included mean changes from baseline, distribution of improved/stable/worsened global QOL and time to deterioration (TTD; ≥10-point worsening in global QOL).
RESULTS: Among 280 randomized patients, 198 (70.7 %) completed QOL at baseline; 121 (43.2 %) had also the 8-week assessment. Arm A led to improved global QOL at week 8 versus arm B, with more patients reporting improvement (24.7 % versus 4.2 %; delta +20.5 %, 95 % confidence interval [CI] +9.1 % - +31.2 %, p = 0.009) and longer TTD (7.6 versus 3.8 months; HR 0.52, 95 % CI 0.33 - 0.82; p = 0.005). Arm A improved role functioning, nausea/vomiting, pain, appetite loss, and dysphagia, while hair loss was more frequent. The improvement was maintained at subsequent timepoints, though not statistically significant. At PD, no differences in symptoms and domains scores were found by treatment arm. EQ VAS scores were numerically higher in arm A at each timepoint except PD.
CONCLUSION: In patients with advanced HER2-negative gastric or gastroesophageal junction cancer, paclitaxel plus ramucirumab switch maintenance showed significant benefit in HRQOL, reducing symptoms and delaying global QOL deterioration.
METHODS: ARMANI was a multicenter, randomized, open-label phase 3 trial. Patients achieving disease control after 3 months of FOLFOX or CAPOX were randomized to paclitaxel plus ramucirumab (arm A) or continued FOLFOX/CAPOX (arm B). HRQOL was assessed using EORTC QLQ-C30, QLQ-OG25, and EQ-5D-5L at baseline and every 8 weeks until progressive disease (PD). Endpoints included mean changes from baseline, distribution of improved/stable/worsened global QOL and time to deterioration (TTD; ≥10-point worsening in global QOL).
RESULTS: Among 280 randomized patients, 198 (70.7 %) completed QOL at baseline; 121 (43.2 %) had also the 8-week assessment. Arm A led to improved global QOL at week 8 versus arm B, with more patients reporting improvement (24.7 % versus 4.2 %; delta +20.5 %, 95 % confidence interval [CI] +9.1 % - +31.2 %, p = 0.009) and longer TTD (7.6 versus 3.8 months; HR 0.52, 95 % CI 0.33 - 0.82; p = 0.005). Arm A improved role functioning, nausea/vomiting, pain, appetite loss, and dysphagia, while hair loss was more frequent. The improvement was maintained at subsequent timepoints, though not statistically significant. At PD, no differences in symptoms and domains scores were found by treatment arm. EQ VAS scores were numerically higher in arm A at each timepoint except PD.
CONCLUSION: In patients with advanced HER2-negative gastric or gastroesophageal junction cancer, paclitaxel plus ramucirumab switch maintenance showed significant benefit in HRQOL, reducing symptoms and delaying global QOL deterioration.
Предметные рубрики MeSH
HumansRamucirumabPaclitaxelFemaleAntineoplastic Combined Chemotherapy ProtocolsAntibodies, Monoclonal, HumanizedStomach NeoplasmsMaleEsophageal NeoplasmsMiddle AgedPatient Reported Outcome MeasuresQuality of LifeEsophagogastric JunctionAgedAdultFluorouracilLeucovorinMaintenance ChemotherapyProgression-Free Survival