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Int J Cancer ; 155(12): 2232-2245, 2024 Dec 15.
Artigo em Inglês | MEDLINE | ID: mdl-39093841

RESUMO

No study has unequivocally proven that chemotherapy prolongs overall survival (OS) in advanced esophageal cancer. We conducted a Phase III randomized study in first-line advanced unresectable/metastatic esophageal/GEJ cancer. Patients aged 18-70 years, with performance status 0-2, were randomized to best supportive care (BSC) alone, or BSC with weekly paclitaxel 80 mg/m2. BSC comprised, as indicated, education, counselling, radiation, stenting, feeding tube placement, nutritional supplementation, medications like analgesics, and referral to a support group and palliative care. The primary endpoint was OS; secondary endpoints included progression free survival (PFS), response, toxicity, and QoL. Between May 2016-December 2020, we recruited 281 patients: 143 to chemotherapy and 138 to BSC. Histopathology was squamous in 269 (95.7%) patients. Median number of paclitaxel doses was 12 (IQR, 7-23). Median OS was 4.2 months (95% CI, 3.42-5.32) in BSC, and 9.2 months (95% CI, 8.02-10.48) in chemotherapy; HR, 0.49 (95% CI, 0.39-0.64); p < .001. As compared to BSC, chemotherapy increased response (2.9% to 39%), median PFS (2.1 to 4.2 months), 1-year OS (11% to 32%), 2-year OS (0 to 9%), median dysphagia-free survival (2.9 to 14.8 months), and global and esophagus-specific QoL, without significantly increasing all-grade or grade ≥3 toxicities. Using ESMO clinical benefit scale and ASCO Value Framework, palliative chemotherapy scored as having "substantial value." Our study provides the first level 1 evidence that chemotherapy prolongs survival in advanced esophageal/GEJ carcinoma. BSC alone is no longer appropriate. Weekly paclitaxel is an attractive option, especially in LMICs with limited access to immunotherapy.


Assuntos
Neoplasias Esofágicas , Paclitaxel , Cuidados Paliativos , Humanos , Neoplasias Esofágicas/terapia , Neoplasias Esofágicas/tratamento farmacológico , Neoplasias Esofágicas/patologia , Cuidados Paliativos/métodos , Pessoa de Meia-Idade , Masculino , Feminino , Idoso , Paclitaxel/administração & dosagem , Paclitaxel/uso terapêutico , Adulto , Qualidade de Vida , Junção Esofagogástrica/patologia , Adulto Jovem , Adolescente , Intervalo Livre de Progressão
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