2024-19344. Supplemental Evidence and Data Request on Medical Therapies for Locally Advanced Gastric Adenocarcinoma

PICOTS (Population, Interventions, Comparators, Outcomes, Timing, and Setting)

PICOTS	Inclusion	Exclusion
Population	All KQs: Adults (18 years or older) with primary, non-recurrent, non-metastatic locally advanced gastric adenocarcinoma stage T2N0 or higher KQ1: Subgroups of interest may include patients who previously received endoscopic therapy or surgery, patients who are non-surgical candidates, and patients with initially unresectable disease KQ2: Subgroups of interest may include patients with gastroesophageal junction (GEJ) cancer	Recurrent cancer, metastatic cancer, early stage (T1aN0 and T1bN0), stage 4 cancer, GEJ cancer patients treated in a predominantly esophageal cancer cohort with an esophageal treatment paradigm, gastrointestinal stromal tumors (GIST), neuroendocrine tumors, gastric lymphoma, MALToma, other rare gastric cancers.
Interventions	All KQs
	Cancer-directed medical therapies administered either alone or in any combination, and may be neoadjuvant, adjuvant, or perioperative (neoadjuvant and adjuvant) and in any sequence: • Chemotherapy including but not limited to: Fluoropyrimidine-based therapy: FOLFOX, XELOX, FLOT, SOX, ECF • Radiation including but not limited to external beam radiation, intra-operative electron radiation • Chemoradiation • HIPEC • Immunotherapy (e.g., ipilimumab, nivolimumab) • Targeted therapy (e.g., anti-HER2 monoclonal antibodies)	• Surgical management exclusively. • Intervention is not well specified (e.g., study reports intervention as “adjuvant chemotherapy” without describing the regimen). • Palliative interventions.
Comparators	All KQs • Any comparator • No comparator (for biomarker-targeted interventions)	N/A.
Outcomes	All KQs • Overall survival • Progression-free survival • Nutritional assessment • Quality of life, using validated scales • Direct moderate-severe treatment adverse events (grade 3, 4, 5) • Direct mild treatment adverse events (grade 1, 2) • Indirect adverse events from treatment (e.g., long-term opioid use for pain management)	N/A.
Timing	All KQs: Any follow-up duration for grade 3-5 or indirect adverse events and quality of life; minimum of 1 year for grade 1-2 adverse events; minimum of 3 months for remaining outcomes	N/A.
Setting	All KQs: • Countries rated as very high on the 2024 Human Development Index (if study is multinational, at least one study center is in a country rated very high)	N/A.
Study Design and Other Criteria	All KQs: • Randomized controlled trials • Non-randomized studies of interventions (experimental or observational) with a concurrent comparator and well-controlled for confounding (at minimum account for age, stage, functional status, and comorbidities) • Single-arm studies (for biomarker-targeted interventions) • Published in English-language • Published in 2006 or later	Case reports, case series, commentaries, cross-sectional studies, reviews, qualitative studies.