scholarly journals Efficacy and safety of nivolumab for advanced gastric cancer patients with poor performance statuses

2020 ◽  
Author(s):  
Toshihiko Matsumoto ◽  
Yosuke Yamamoto ◽  
Yusuke Kurioka ◽  
Ukyo Okazaki ◽  
Shogo Kimura ◽  
...  

Abstract Background: Nivolumab has changed the treatment of advanced gastric cancer (AGC). Nivolumab shows better outcomes compared to best supportive care among AGC patients who received at least two prior regimens. However, there are no reliable data regarding AGC patients with poor performance status (PS) who received nivolumab. We investigated the efficacy and safety of nivolumab among AGC patients with poor PS. Methods: We retrospectively collected clinicopathologic data from patients with AGC who underwent nivolumab monotherapy at our institution from October 2017 to June 2019. Results: Forty-nine AGC patients who received nivolumab were assessed. Twenty-seven patients had PS 0 or 1 (Good group) and 22 had PS 2 or 3 (Poor group). The median progression-free survival and overall survival durations were 61 and 180 days in the Good group, respectively, and 36 and 85 days in the Poor group, respectively. The overall survival was significantly shorter in the Poor group (180 vs 85 days, p =0.0255). The disease control rates were 23% and 9% in the Good and Poor groups, respectively. Thirty-three percent of patients experienced immune-related adverse events in the Good group, and 18% in the Poor group. Conclusion: Nivolumab has a modest effect and is feasible as third- or later-line treatment for AGC patients.

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 391-391
Author(s):  
Toshihiko Matsumoto ◽  
Ukyo Okazaki ◽  
Yusuke Kurioka ◽  
Shogo Kimura ◽  
Takao Tsuzuki ◽  
...  

391 Background: Nivolumab has changed the treatment of advanced gastric cancer (AGC). Nivolumab shows better outcome compared to best supportive care in AGC patients who received at least two prior regimen. Although there is not reliable date of poor performance status(PS) AGC patients who received nivolumab. We investigated efficacy and safety of nivolumab for AGC patients with poor PS. Methods: We retrospectively collected clinicopathologic data from patients with AGC who received nivolumab monotherapy in Himeji Red Cross Hospital from October 2017 to June 2019. Results: 49 AGC patients who received nivolumab were analyzed. 27 patients were PS 0 or 1(Good Group), and 22 patients were PS 2 or 3(Poor Group). Median progression free survival and overall survival was 61 days and 180 days in Good Group and 36 days and 85 days in Poor Group. Overall survival (OS) was significantly shorter in Poor group(180 days vs 85 days, p = 0.0255). Disease control rate was 23% in Good group and 9% in Poor group. 33% patients were experienced immune related adverse event (iRAE) in Good Group, and 18% in Poor Group. We investigated prognostic factor of OS in Poor Group such as Royal Marsden Hospital Score(RMH score), modified Glasgow prognostic score(mGPS), and Japan Clinical Oncology Group (JCOG) prognostic index. RMH score and JCOG prognostic index good or moderate group was significantly longer overall survival than poor group (93 days vs 35 days (p = 0.0214)). JCOG prognostic index was most correlated with OS among these tools. Conclusions: This study suggested that nivolumab has a modest effect and is feasible as third line or later line for AGC patients. JCOG prognostic index was suggested to be effective in predicting prognosis in AGC patients who received nivolumab.


2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 392-392
Author(s):  
Akinori Sugaya ◽  
Shunsuke Ueyama ◽  
Hirosumi Suzuki ◽  
Takeshi Yamada ◽  
Yoshiyuki Yamamoto ◽  
...  

392 Background: Nivolumab is a standard of care as the later-line therapy for advanced gastric cancer. However, there are few data about efficacy and safety of nivolumab for pts with malignant ascites. Methods: We conducted a multicenter retrospective study for pts with advanced gastric cancer who received nivolumab alone from Oct. 2017 to Feb. 2019. Pts were divided into two groups; high ascites burden (HAB) with moderate or massive ascites and non-HAB with none or a small amount of localized ascites at pelvis and/or liver surface. Results: A total of 72 pts (23 pts with HAB and 49 pts with non-HAB) were evaluable. The HAB group had more pts with young (median 62 vs 70 years), female (35 vs 14 %), no prior gastrectomy (63 vs 35 %) and poor performance status (PS > 1; 26 vs 10 %), compared to the non-HAB group. Disease control rate was 44% (95% CI 23-64%) in the HAB group and 57% (95% CI 43-71%) in the non-HAB group. Ascites decreased in 4 pts (17%) and completely disappeared in 2 pts (8.7%) in the HAB group. These 6 pts were all male and had prior ramucirumab treatment with a mean neutrophil-lymphocyte ratio 2.1 (from 0.85 to 3.7) at the initiation of nivolumab. After 5 months of follow up period, disease progression or death events for progression-free survival (PFS) occurred in 74% of the HAB group and 53% of the non-HAB group. Median PFS was 1.0 (95%CI 0.5-1.5) and 2.6 (95%CI 0.9-7.4) months in pts with HAB and non-HAB, respectively. PFS rates at 6 months were 31% in the HAB group and 33% in the non-HAB group. Immune-related adverse events occurred in 26% of the HAB group and 16% of the non-HAB group including one and two pts with grade 3 or 4 events, respectively. There was no treatment-related death in both groups. Conclusions: Although pts with HAB showed trends of worse outcomes compared with those with non-HAB, nivolumab was suggested to provide a survival benefit to some pts with HAB, and was tolerable in the HAB group.


1986 ◽  
Vol 4 (9) ◽  
pp. 1348-1355 ◽  
Author(s):  
J A Levi ◽  
R M Fox ◽  
M H Tattersall ◽  
R L Woods ◽  
D Thomson ◽  
...  

A multi-institutional cooperative study of patients with locally advanced, recurrent, or metastatic gastric adenocarcinoma who had not previously received chemotherapy was conducted, prospectively randomizing patients to receive either doxorubicin or the three-drug combination, 5-fluorouracil (5-FU), doxorubicin (Adriamycin; Adria Laboratories, Columbus, Ohio), and BCNU (FAB). The 187 evaluable patients were initially stratified according to the presence of measurable or evaluable disease and performance status. There was a significantly higher response rate observed for FAB (40%) compared with doxorubicin (13%) among the 145 measurable-disease patients. Duration of response and survival were significantly longer for FAB in the measurable-disease group, but for the total patient population an early advantage for FAB in time to disease progression and survival was lost with continued follow-up. Median survival was 33 weeks for patients receiving FAB and 19 weeks for those receiving doxorubicin. Significant pretreatment factors adversely affecting survival included poor performance status, weight loss of greater than 10%, and more than two sites of metastases. Toxicity was not severe in either treatment arm, and only thrombocytopenia occurred significantly more often with FAB. It is contended that in the treatment of advanced gastric cancer, chemotherapy only exerts a relatively short-term and modest beneficial effect, most apparent in patients with intermediate tumor bulk. 5-FU remains the most active single agent, and combination chemotherapy has not yet proven its overall worth. Further studies are indicated comparing the most active combinations with 5-FU using optimal doses and schedules, and consideration must be given to the incorporation of no-treatment controls.


2019 ◽  
Vol 2019 ◽  
pp. 1-4
Author(s):  
Hieu Van Nguyen ◽  
Hung Van Nguyen ◽  
Long Thanh Nguyen ◽  
Nga Quynh Pham ◽  
Hau Xuan Nguyen ◽  
...  

Introduction. In advanced gastric cancer, preoperative chemotherapy is associated with survival benefit. FOLFIRI has demonstrated promising results in terms of survival and tolerance, especially in patients with poor performance status. Case Presentation. A 59-year-old male, diagnosed with pT4bN2M0 gastric cancer, underwent gastrointestinal anastomosis and three cycles of EOX chemotherapy. Due to disease progression, he was switched to FOLFIRI regimen. After 12 cycles, the patient received a subtotal gastrectomy and D2 lymphadenectomy. Microscopic examination achieved pCR, and the patient has been surviving 34 months without recurrence. No severe toxicities of chemotherapy were recorded. Conclusions. FOLFIRI might be a safe and effective option in neoadjuvant treatment for advanced gastric cancer among patients with poor performance status or progression after first-line chemotherapy.


2018 ◽  
Vol 07 (04) ◽  
pp. 223-225 ◽  
Author(s):  
Bhat Guruprasad

Abstract Background: Gastric carcinoma is the leading cause of cancer in south India. Gastric cancer is frequently diagnosed in locally advanced or metastatic setting in Indian scenario and has a poor survival. There is no standard chemotherapy regimen which can be used in advanced gastric cancer (AGC) patients. Objective: The aim of this study was to assess the clinical activity and toxicity of oxaliplatin with infusional 5-fluorouracil and leucovorin administered every 3 weeks in patients with locally advanced and inoperable gastric cancer. Patients and Methods: In this retrospective study, the case records of 25 patients who have received OLF regimen were analyzed. Results: The median number of cycles for patients was 6 (range: 4–12 cycles). Overall response rate was 36%, with all patients having stable disease. Median survival of patients was 6 months (7 months in locally advanced). Compared to other regimens, there was less toxicity (less hematologic toxicity, less nausea and vomiting, no hair loss, no renal toxicity, no hand foot syndrome, and lesser admissions). Conclusions: OLF regimen is an acceptable regimen in poor performance status AGC patients with adequate response and an acceptable toxicity profile.


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