scholarly journals A post-marketing observational study of ramucirumab in patients with gastric cancer in Japan

2021 ◽  
Author(s):  
Yucherng Chen ◽  
Taeko Katayose ◽  
Soshi Nagaoka ◽  
Yongzhe Piao ◽  
Kensei Yamaguchi ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Combination Therapy ◽  
Adverse Events ◽  
Confidence Interval ◽  
Advanced Gastric Cancer ◽  
Real World ◽  
Gastric Perforation ◽  
Real World Setting ◽  
Post Marketing ◽  
Grade 3

Abstract Background This study evaluated the safety and effectiveness of ramucirumab monotherapy and combination therapy for advanced gastric cancer in the real-world setting. Methods This single-arm, prospective, multicenter, non-interventional, observational, post-marketing study was conducted in Japan from August 2015 to March 2019. Patients with unresectable advanced or recurrent gastric cancer and newly prescribed ramucirumab were followed for up to 12 months after first treatment. Data on adverse events and survival were collected via Electronic Data Capture. Results Of 687 enrolled patients, 658 were eligible for analysis. Most patients received either ramucirumab monotherapy (123/658; 18.7%) or ramucirumab plus paclitaxel combination therapy (528/658; 80.2%). The majority of patients reported ≥ 1 adverse events in both the combination therapy (any grade, 479/528; 90.7%; ≥ Grade 3, 321/528; 60.8%) and monotherapy groups (any grade, 77/123; 62.6%; ≥ Grade 3, 42/123; 34.2%). The most common any grade adverse events were neutropenia (combination: 49.6%; monotherapy: 8.9%), fatigue (combination: 19.5%; monotherapy: 13.8%), and decreased appetite (combination: 18.2%; monotherapy: 10.6%). Grade 5 adverse events were reported in 4 patients, including metastases to meninges, pneumonia aspiration, death, and gastric perforation; of these, gastric perforation was deemed treatment-related. Median survival time was 5.7 months (95% confidence interval: 4.1–6.8 months) following monotherapy and 11.0 months (95% confidence interval: 9.8–12.2 months) following combination therapy. Conclusions This analysis adds to the limited data available on ramucirumab use in a real-world setting, demonstrating similar safety and effectiveness for ramucirumab in treating advanced gastric cancer in routine clinical practice in Japan to that of global clinical trials.

Prophylaxis of neutropenia with mecapegfilgrastim in patients with non-myeloid malignancies in a real-world setting.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e24072-e24072
Author(s):  
Jun Ma ◽  
Huiqiang Huang ◽  
Peifen Fu ◽  
Nong Xu ◽  
Chenyu Mao ◽  
...  
Keyword(s):  
Adverse Events ◽  
Real World ◽  
Study Drug ◽  
Secondary Prophylaxis ◽  
Chemotherapy Cycle ◽  
Breast Cancer Patients ◽  
Continuous Administration ◽  
Real World Setting ◽  
Grade 3 ◽  
Long Acting

e24072 Background: The prophylaxis of neutropenia has been evolving from short acting granulocyte colony-stimulating factors (G-CSFs) to long acting G-CSFs. The safety and effectiveness of long acting G-CSF in a real-world setting were still lacking. Methods: We performed a multi-center, non-interventional, real-world study to explore the tolerability and effectiveness of mecapegfilgrastim. Different prophylactic strategy (primary or secondary prophylaxis) were compared. The effect of mecapegfilgrastim by means of continuous administration was also explored. Results: This study included 638 patients who had complete the study from May 2019 to November 15, 2020. About half of the participants were breast cancer patients. The mean age of the patients were 56 years. The most frequently reported adverse event possibly related to study drug was white blood cell increase (6.2 %). No unexpected adverse events were reported. Overall, thirty-six (5.6 %) patients experienced grade ≥ 3 neutropenia in chemotherapy cycle one. The patients in the primary and secondary prophylaxis subgroups had incidence of grade ≥ 3 neutropenia of 4.3 % and 9.2 % in chemotherapy cycle one respectively. There was a decreasing trend of neutropenia from cycle one to cycle four when mecapegfilgrastim were administrated continuously. Conclusions: The mecapegfilgrastim was well tolerable and no unexpected adverse events were observed in real-world setting. Primary prophylaxis using mecapegfilgrastim had lower incidence of neutropenia than secondary usage.

Treatment of locally advanced or multiple basal cell carcinoma with vismodegib in real world setting.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e22065-e22065
Author(s):  
Janja Ocvirk ◽  
Tanja Mesti ◽  
Katja Leskovsek
Keyword(s):  
Basal Cell Carcinoma ◽  
Adverse Events ◽  
Cell Carcinoma ◽  
Real World ◽  
Locally Advanced ◽  
Muscle Cramps ◽  
Real World Setting ◽  
Previously Treated ◽  
Baseline Characteristics ◽  
Grade 3

e22065 Background: Evaluation of efficacy and safety of vismodegib (V) was done in a retrospective analysis of patients (pts) with locally advanced or multiple basal cell carcinoma (laBCC or multiple BCC) and pts with Goltz-Gorlin Syndrom (G-G Syn) in routine clinical practice. Methods: Baseline characteristics, efficacy data and treatment-related adverse events were collected from 30 laBCC or multiple BCC and 6 G-G Syn pts who were treated with V. Results: In 86-month period, 36 pts were diagnosed with laBCC (18 pts), multiple BCC (12 pts) or G-G Syn (6 pts), all inappropriate for surgery or radiotherapy. Baseline characteristics: median age was 72.6 years in laBCC + multiple BCC pts group and 51.3 years in G-G Syn pts group. Sixty percent of pts in laBCC + multiple BCC group were females; majority (70%) of pts were previously treated by surgery (S) and/or radiotherapy (RT); 43% of pts had 1 lesion with predominant localization in central face (eyes, nose, lips or ears in 84% of pts), 20% had 2-3 lesions and 37% more than 3 lesions. Fifty percent of pts in G-G Syn pts group were males; all pts were previously treated with S and/or RT. The overall response rate (ORR) was 76% in laBCC + multiple BCC and 83% in G-G Syn pts group. Disease control rate (DCR) was 93% in laBCC + multiple BCC and 100% in G-G Syn pts group. Median duration of treatment (DoT) was 7.8 months (range: 1.3-29.8) in laBCC + multiple BCC group and 27.1 months (range: 4.8-86.4) in G-G Syn group. At the time of analysis in laBCC or multiple BCC group one patient died due to other reasons than cancer, in 30% of pts treatment has been interrupted during the treatment course [in most cases due to complete response or adverse events (AEs)], 40% of pts are still on treatment. In G-G Syn group treatment has been interrupted in 50% of pts (in most cases due to adverse events), 67% of pts are still on treatment. AEs of any grade were reported in 97% of pts in laBCC or multiple BCC group and 83% in G-G Syn group. Majority of AEs in laBCC or multiple BCC group were grade 1 or 2 (96%)., 4% of AEs were grade 3: muscle cramps in 3 pts, respiratory infection, vomiting and anemia in 1 patient each. Majority of AEs in G-G Syn group were also grade 1 or 2 (87%), 13% of AEs were grade 3: muscle cramps in 2 pts, weight loss and diarrhea in 1 patient each. No grade 4 or 5 AEs were reported. Conclusions: Vismodegib has shown meaningful efficacy with manageable safety profile in pts with laBCC or multiple BCC as well as in pts with G-G Syn in real world setting.

Efficacy and safety of apatinib in treatment of gastric cancer: A real-world study.

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 182-182
Author(s):  
Yijie Ma ◽  
Hong Zong ◽  
Junsheng Wang ◽  
Yanzhen Guo ◽  
Huaimin LIU ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Adverse Events ◽  
Real World ◽  
Progression Free Survival ◽  
Complete Response ◽  
Efficacy And Safety ◽  
Efficacy Evaluation ◽  
Third Line ◽  
Grade 3 ◽  
Gastric Cancer Patients

182 Background: Apatinib is a small molecule TKI inhibitor, which had been approved in China for treatment of advanced gastric cancer refractory to two or more lines of prior chemotherapy. Its efficacy and safety have been demonstrated in previous randomized controlled clinical studies. However, the efficacy and safety of apatinib in real world is lacking. This study aimed to evaluate the anti-tumor activity and toxicity of apatinib in real world. Methods: Patients older than 18 years with histologically diagnosed with gastric cancer were enrolled and treated with either apatinib alone or in combination with other drugs. The primary endpoint was progression-free survival (PFS), and secondary endpoints were overall survival (OS), overall response rate (ORR) and disease control rate (DCR). The adverse events were also recorded. Results: From March 2018 to March 2019, a total of 1000 patients were enrolled. Among them, 48(0.48%), 13(0.13%), 225 (22.5%), 389 (38.9%), and 325 (32.5%) patients received apatinib as postoperative auxiliary-, neoadjuvant-, first-, second-, and third- or higher line therapy, respectively. Efficacy evaluation was performed in 901 patients. Thirty-five patients achieved complete response (CR), 116 patients achieved partial response (PR), 596 patients achieved stable disease (SD), and 154 patients had progressive disease (PD), illustrating an ORR of 16.76% and a DCR of 82.91%. The mPFS was 5.32 months (95% CI, 4.93-5.75), and mOS was 9.76 months (95% CI, 8.97-10.81). In addition, the mOS of apatinib in first-line, second-line, and third-line treatments were 12.68 months, 9.49 months, and 7.62 months, respectively. Patients received apatinib in combination with other drugs had longer survival than apatinib alone, with mPFS 5.62 months vs 4.47 months and mOS 10.81 months vs 7.95 months. Such phenomenon was also observed in ORR (18.21% vs 13.04%, P< 0.001) and DCR (84.88% vs 77.87%, P< 0.001). The main adverse events (AE) were anemia (67.2%), thrombocytopenia (36.2%), leukopenia (34.5%)and anorexia (37.6%). The most common grade 3-4 adverse events included neutropenia, anemia and thrombocytopenia. Conclusions: In the real world, apatinib showed promising efficacy and manageable toxicities in patients with gastric cancer. Patients benefit more when received apatinib combination therapy. Clinical trial information: NCT03478943.

A multicenter phase II study of combination therapy with oral S-1 plus cisplatin in elderly patients with advanced gastric cancer.

2017 ◽  
Vol 35 (4_suppl) ◽  
pp. 157-157
Author(s):  
Tetsuji Terazawa ◽  
Satoru Iwasa ◽  
Yusuke Sasaki ◽  
Shunsuke Okazaki ◽  
Masahiro Goto ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Combination Therapy ◽  
Adverse Events ◽  
Elderly Patients ◽  
Advanced Gastric Cancer ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Progression Free Survival ◽  
Patient Characteristics ◽  
Gastric Cancer Patients

157 Background: The incidence of gastric cancer increases gradually in individuals aged ≥ 75 years who account for about 40% of all patients. From the SPIRITS study, comparing S-1 monotherapy with S-1 and cisplatin (CDDP) combination therapy (median overall survival [OS]: 11.0 versus 13.0 months, p=0.04), S-1 and CDDP chemotherapy (SP regimen) is recognized as one of the standard first-line regimens for patients with advanced gastric cancer in Japan. However, patients in this trial were aged < 75 years. Methods: The aim of this phase II study was to evaluate the efficacy and safety of SP regimen in elderly patients with chemotherapy-naive advanced gastric cancer. Patients aged ≥ 76 years were given oral S-1 twice daily for 21 days, followed by 14 days rest; CDDP was intravenously infused at day 8, repeated every 35 days, for up to eight cycles. The dose of S-1 (50–120 mg/body) and CDDP (30–60 mg/m2) was adjusted depending on the patient’s body surface area and creatinine clearance (Ccr-adjusted SP regimen). The primary endpoint was OS. The threshold and expected OS were estimated at 8 and 14 months, respectively. Secondary endpoints included response rate (RR), progression-free survival (PFS), time to treatment failure (TTF) and adverse events. Results: From December 2012 to October 2014, 40 patients were enrolled at 15 institutions. Patient characteristics were: gender (M/F) 29/11; median age 78 (range, 76–89); ECOG PS0/1, 13/27; and unresectable/recurrence 30/10. The median cycle for each patient was four (range, 1–8). The median OS was 12.3 months (80% confidence interval, 10.2–14.4 months). The median PFS and TTF were 7.8 and 4.3 months, respectively. The RR was 54%. A dose reduction of S-1 and CDDP was made for 30% and 35% of patients, respectively. The protocol was discontinued in 17 patients (43%) for disease progression, 10 patients (25%) for adverse events and 7 patients (17%) for patient refusal. The main adverse events at a grade 3 or higher were anorexia (25%), neutropenia (23%), hyponatremia (20%) and anemia (18%). Treatment-related deaths did not occur. Conclusions: Ccr-adjusted SP regimen showed promising activity and was tolerated well by elderly patients with advanced gastric cancer. Clinical trial information: UMIN000009349.

Clinical observation of nab-paclitaxel plus S-1 as first-line chemotherapy for advanced gastric cancer.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e15554-e15554
Author(s):  
Yi Hu ◽  
Danyang Sun
Keyword(s):  
Gastric Cancer ◽  
Combination Therapy ◽  
Advanced Gastric Cancer ◽  
Median Overall Survival ◽  
Overall Response Rate ◽  
Standard Treatment ◽  
Therapeutic Option ◽  
First Line ◽  
Grade 3 ◽  
Line Setting

e15554 Background: Gastric cancer is the third leading cause of death in the world with poor prognosis. Until recently, no standard treatment was available for patients with advanced gastric cancer in the first-line setting. Nab-paclitaxel and S-1 were both proved to have antitumor activity in many solid tumors including gastric cancer. We aimed to evaluate the efficacy and tolerance of nab-paclitaxel in combination with S-1. Methods: Patients with unresectable or recurrent gastric cancer received combination therapy of nab-paclitaxel plus S-1 every 3 weeks as one cycle. Nab-paclitaxel was administered at total dose of 260mg/ m2 on day 1 and 5 or on day 1 and 8. S-1 was given orally twice a day for 14 days, the doses were assigned according to body surface area. S-1 alone was administered as maintenance therapy after 6 to 8 cycles of combination therapy until disease progression. Results: Among the 33 patients enrolled, 28 patients (84.8%) had KPS 90, one third of patients were recurrent after gastrectomy. They received an average of 5.7 cycles of combination treatment. The median PFS was 6.6 months (95%CI, 5.557-7.716 months). The overall response rate was 51.5%, with one CR, 16 PR, 16 SD, and no PD. The median overall survival time was not obtained at the time of analysis. In safety profile, the highest incidence rate of grade 3 and grade 4 adverse events was neutropenia (12.1%). Conclusions: The combination of nab-paclitaxel plus S-1 was well tolerated and presented antitumor efficacy which may be a new therapeutic option for patients with advanced gastric cancer.

Real-world observation of the efficacy and prognostic factors analysis of apatinib for patients with advanced gastric cancer.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e15508-e15508
Author(s):  
Qiwen Shen ◽  
Mingyun WANG ◽  
Xiaobao Peng ◽  
Siyi Tan ◽  
Jiaqi Xie ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Prognostic Factors ◽  
Adverse Events ◽  
Advanced Gastric Cancer ◽  
Real World ◽  
Progression Free Survival ◽  
Clinical Decision ◽  
Factors Analysis ◽  
One Year ◽  
Metastatic Sites

e15508 Background: Apatinib is the first oral anti-angiogenic agent approved for the treatment of advanced gastric cancer in China. With the development of marketing promotion, the real world observation of the efficacy and prognostic factors analysis of apatinib become the urgent need for clinical decision. The aim of this study is to evaluate the efficacy and safety of apatinib in patients with advanced gastric cancer, and the association between some prognostic factors and clinical outcomes. Methods: We collected the data of 153 patients with advanced gastric cancer, who were treated with apatinib after failure of at least one regimen chemotherapy from December 2014 to June 2019. Treatment response, progression-free survival(PFS), overall survival(OS) and treatment-related adverse events were evaluated. Results: The median PFS for 153 patients was 3.1m (95% confidence interval, CI 2.863-3.337). The median OS was 6.0m (95% CI 4.392-7.608). Adverse events of grade 3 or above happened in 47.6 percent of patients and 61.7 percent of whom stopped treatment. Multivariate analysis showed that the number of metastatic sites was the independent factor simultaneously predicting DCR (disease control rate, P = 0.008) and OS (P = 0.007). Patients spending more than one year from diagnosis to treatment with apatinib had better DCR (P = 0.032) and longer PFS (P = 0.015). Liver metastasis (P = 0.007) and combined systemic therapy (P = 0.036) were significantly associated with DCR, but not associated with PFS or OS. Conclusions: Some patients with advanced gastric cancer can benefit from apatinib. This study help us to identify patients who has potential benefit from apatinib.

Results of a phase II trial of ramucirumab plus irinotecan as second-line treatment for patients with advanced gastric cancer (HGCSG 1603).

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 217-217
Author(s):  
Yasuyuki Kawamoto ◽  
Satoshi Yuki ◽  
Kentaro Sawada ◽  
Michio Nakamura ◽  
Osamu Muto ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Combination Therapy ◽  
Adverse Events ◽  
Advanced Gastric Cancer ◽  
Primary Endpoint ◽  
Causal Relation ◽  
Growth Factor Receptor ◽  
Progression Free Survival ◽  
Line Treatment ◽  
Second Line

217 Background: Ramucirumab (RAM) is a fully human IgG1 monoclonal vascular endothelial growth factor receptor-2 (VEGFR-2) antibody. The RAINBOW trial showed RAM plus paclitaxel (PTX) increased overall survival (OS) compared with PTX alone for advanced gastric cancer (AGC) in second-line treatment. WJOG 4007 trial demonstrated equivalent efficacy between irinotecan (IRI) and PTX. We conducted this trial to examine the efficacy and safety of RAM plus IRI combination therapy in the second-line treatment for AGC. Methods: This non-randomized, single arm, phase 2 trial was carried out at 22 institutes in Japan. AGC patients with refractory or intolerance to primary chemotherapy were eligible. RAM 8 mg/kg and IRI 150 mg/m2 combination therapy administered every two weeks were continued until progression or emergence of adverse events requiring discontinuation. The primary endpoint was progression-free survival (PFS) rate at six-month, the target was set as 16% with an expected threshold of 39%. A total of 35 cases are planned for registration. The secondary endpoints were OS, PFS, response rate (RR) and safety. This trial was registered with Japan Registry of Clinical Trials, number jRCTs011180029. Results: Between Jan 2018 and Sept 2019, 35 patients were enrolled. Median age was 70 (range, 47-80); female/male were 10/25; ECOG PS 0/1, 22/13. PFS rate at six months was 26.5% (95%C.I., 13.2-41.8%, p = 0.1353). Median PFS and OS were 4.2 (95%C.I., 2.5-5.4 months) and 9.6 months (95%C.I., 6.5-16.6 months), respectively. RR was 26% and disease control rate was 85%. Grade 3 or higher adverse events that occurred in more than 5% of patients were neutropenia (51%), leucopenia (43%), anemia (20%), anorexia (14%), febrile neutropenia (11%), diarrhea (9%), hypertension (9%), proteinuria (9%), hypokalemia (9%), hypoalbuminemia (9%), thrombocytopenia (6%), and hyponatremia (6%). No death and new safety signals with a causal relation to study treatment were observed. Conclusions: Although the primary endpoint was not achieved statistically, the results are clinically encouraging, especially take into account that more elderly patients enrolled in this trial. The combination of RAM plus IRI has anti-cancer activity and manageable safety profile in second-line treatment for patients with AGC. Clinical trial information: jRCTs011180029.

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