Systemic therapy beyond first-line in advanced gastric cancer: An overview of the main randomized clinical trials

Galdy, Salvatore; Cella, Chiara Alessandra; Spada, Francesca; Murgioni, Sabina; Frezza, Anna Maria; Ravenda, Simona Paola; Zampino, Maria Giulia; Fazio, Nicola

doi:10.1016/j.critrevonc.2015.09.004

Cited by 21 publications

(20 citation statements)

References 52 publications

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“…Geographical differences are evident in gastric cancer between Asian and Western countries in incidence rates, tumor location, stage presentation, treatment patterns, prognosis, and survival [10-14]. The RAINBOW trial reported efficacy by geographic region, with those from Asian countries showing longer median PFS (5.5 months, 95% CI: 4.2–5.7) and OS (12.1 months, 95% CI: 10–13.3).…”

Section: Discussion/conclusionmentioning

confidence: 99%

“…The authors speculated that the geographic region difference in treatment effect was a result from the higher use of subsequent therapy in Asia than in Western countries. The role of second-line therapy has traditionally been a state of debate in Western countries, with reports of only 50% of patients in Western countries offered second-line therapy; conversely, almost all patients in Japan receive second-line therapy, and more than half receive third-line therapy [10-14]. Concerns with performance status and toxicity of therapy have limited the use of second-line therapy in Western countries.…”

Section: Discussion/conclusionmentioning

confidence: 99%

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Ramucirumab and Paclitaxel Administered Every 2 Weeks (mRAINBOW Regimen) in Advanced Gastroesophageal Adenocarcinoma

et al. 2019

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Background: The RAINBOW trial established ramucirumab combined with paclitaxel as a second-line option in metastatic gastric and gastroesophageal junction (GEJ) adenocarcinoma. Ramucirumab was given on days 1 and 15 with paclitaxel on days 1, 8, and 15 of a 28-day cycle. The median overall survival (OS) was significantly longer with ramucirumab plus paclitaxel (p = 0.017), and it led to 41% grade 3 or higher neutropenia. We review our experience with both ramucirumab plus paclitaxel given biweekly (mRAINBOW) to assess efficacy and safety. Objectives: The primary objective was to assess OS. Secondary end points were progression-free survival (PFS), overall response, and safety. Methods: We identified 129 patients retrospectively from our database between November 2014 and May 2017. Patients were included if they were followed up at our institution. Results: Median doses given were ramucirumab 8 mg/kg i.v. plus paclitaxel 110 mg/m² i.v. given once every 2 weeks. The median performance status was 1, and ∼60% had poorly differentiated histology; 55.8% had progression in < 6 months on first-line therapy, and the majority had measurable cancer. Median overall OS and PFS for the entire cohort was 9.4 months (95% CI: 8.05–10.74) and 3.68 months (95% CI: 2.73–4.5), respectively. Median OS was 9.46 months (95% CI: 8.05–14.95) and median PFS was 4.14 months (95% CI: 2.96–5.29) in those patients that received ramucirumab plus paclitaxel in the second-line setting. Conclusion: Biweekly administration of ramucirumab plus paclitaxel did not compromise efficacy. Delays, adjustments, or doses held were similar to the RAINBOW trial, with 31% requiring a dose or schedule modification.

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Section: Discussion/conclusionmentioning

confidence: 99%

Section: Discussion/conclusionmentioning

confidence: 99%

Ramucirumab and Paclitaxel Administered Every 2 Weeks (mRAINBOW Regimen) in Advanced Gastroesophageal Adenocarcinoma

et al. 2019

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“…In addition, the use of irinotecan in lieu of taxanes might be successful from a strategic point of view. In fact, early disease relapse, a frequent event, might still be treated with an effective second-line therapy with paclitaxel and ramucirumab [24] .…”

Section: Discussionmentioning

confidence: 99%

Preoperative Capecitabine, Oxaliplatin, and Irinotecan in Resectable Gastric or Gastroesophageal Junction Cancer: Pathological Response as Primary Endpoint and FDG-PET Predictions

et al. 2017

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Objectives: This phase II trial was aimed at assessing the safety and activity of capecitabine, oxaliplatin, and irinotecan (COI regimen) as a preoperative treatment for resectable gastric cancer (GC) or gastroesophageal junction (GEJ) cancer. Methods: Patients affected by T3-T4/N0-N+/M0 GC/GEJ cancer were treated with the COI regimen for 4 cycles followed by restaging and gastroresection with D2 lymphadenectomy. Four postoperative cycles were scheduled. The primary endpoint was pathological response rate according to Becker et al. [Cancer 2003;98:1521-1530]. The potential role of fluorodeoxyglucose positron emission tomography/computed tomography (FDG-PET/CT) as a predictive biomarker of pathological tumor response was assessed in a subgroup of 19 evaluable patients. Results: Between January 2011 and October 2015, a total of 40 patients were enrolled. After the preoperative phase, 36 out of 40 patients (90%) were considered eligible for surgery: 12 patients (30%) achieved a pathological response. The most frequent grade 3/4 adverse events were diarrhea (27%), nausea (25%), and fatigue (17%). Grade 3 neutropenia occurred in 7.5% of patients. A lower standard uptake value at baseline FDG-PET/CT was associated with pathological response. Conclusion: COI combination is active with a manageable toxicity profile in patients with resectable GC or GEJ cancer. FDG-PET/CT imaging as a surrogate biomarker of pathological response in this setting appears fascinating but should be further investigated.

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“…2019; (19): [104][105][106][107][108][109][110][111][112][113] Вторая линия лекарственной терапии вносит существенный вклад в увеличение общей выживаемости больных. Стандартом является монотерапия препаратами, не вошедшими в состав первой линии лечения, такими как иринотекан, доцетаксел, паклитаксел, эффективность которых одинакова [13][14][15][16].…”

Section: оригинальные исследованияunclassified

Tolerance of ramucirumab in the second-line therapy of patients with disseminated gastric cancer in the routine clinical practice of Russia

Бесова¹,

Титова²,

Артамонова³

et al. 2019

Medicinskij sovet

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Резюме Введение. Рамуцирумаб-моноклональное антитело, ингибирующее рецепторы фактора роста эндотелия сосудов 2-го типа (VEGFR2). Целью исследования являлся анализ результатов применения рамуцирумаба во 2-й линии лечения больных диссеминированным раком желудка в реальной клинической практике России. Методы. В анализ были включены ретроспективные данные из 11 онкологических центров. Оценена специфическая токсичность. Результаты: во второй линии лечения рамуцирумаб был назначен 163 больным: в монорежиме-17, в комбинации с паклитакселом-104, в комбинации с режимами на основе иринотекана-42 пациентам. Специфическая для рамуцирумаба токсичность (любой степени) была представлена: носовыми кровотечениями (39,2%), протеинурией > 1 г/день (4,9%), артериальной гипертензией (68%), токсичность 3-4-й степени-кровотечением (4,3%), гастроинтестинальными перфорациями (2,4%), венозными тромбозами (3,6%) и ишемией головного мозга (0,6%), лечение прекращено из-за токсичности у 15 больных (9,2%). Заключение. Полученные данные соответствуют результатам рандомизированных исследований. Рамуцирумаб в комбинации с иринотеканом и фторпиримидинами демонстрирует высокую активность, приемлемую токсичность, может быть рекомендован для практического применения и дальнейшего изучения в сравнительных рандомизированных исследованиях.

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Systemic therapy beyond first-line in advanced gastric cancer: An overview of the main randomized clinical trials

Cited by 21 publications

References 52 publications

Ramucirumab and Paclitaxel Administered Every 2 Weeks (mRAINBOW Regimen) in Advanced Gastroesophageal Adenocarcinoma

Ramucirumab and Paclitaxel Administered Every 2 Weeks (mRAINBOW Regimen) in Advanced Gastroesophageal Adenocarcinoma

Preoperative Capecitabine, Oxaliplatin, and Irinotecan in Resectable Gastric or Gastroesophageal Junction Cancer: Pathological Response as Primary Endpoint and FDG-PET Predictions

Tolerance of ramucirumab in the second-line therapy of patients with disseminated gastric cancer in the routine clinical practice of Russia

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