A phase II trial of trastuzumab combined with irinotecan in patients with advanced HER2-positive chemo-refractory gastric cancer: OGSG1203 (HERBIS-5).

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 128-128 ◽  
Author(s):  
Kazuhiro Nishikawa ◽  
Daisuke Sakai ◽  
Junji Kawada ◽  
Ryohei Kawabata ◽  
Tomono Kawase ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Overall Survival ◽  
Disease Control ◽  
Intravenous Infusion ◽  
Response Rate ◽  
Progression Free Survival ◽  
Disease Control Rate ◽  
Efficacy And Safety ◽  
Her2 Positive ◽  
Free Survival

128 Background: Irinotecan is a key drug in second- or further-line chemotherapy for patients with advanced gastric cancer. Continuous administration of trastuzumab beyond first progression is expected to contribute to the benefit of chemotherapy for HER2-positive gastric cancer. We assessed the efficacy and safety of combination chemotherapy with trastuzumab and irinotecan in Japanese patients with advanced HER2-positive chemo-refractory gastric cancer. Methods: Intravenous infusion of irinotecan every 2 weeks at a dose of 150 mg/m2; intravenous infusion of trastuzumab at a dose of 8 mg/kg on day 1 of the first cycle, followed by 6 mg/kg every 3 weeks. Administration of irinotecan and trastuzumab were repeated in independent schedules. The primary endpoint was disease control rate. The secondary endpoints were adverse events, response rate, time-to-treatment failure, progression-free survival, overall survival, and response rate stratified by prior trastuzumab use. This study was conducted by the Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG). Results: From October 2012 to Augst 2014, 30 patients were enrolled and one patient withdrew before study treatment. Accordingly, 29 patients were assessable for efficacy and safety. The disease control rate was 65.5% [95% C.I. 45.7 - 82.1%], and the response rate was 20.7% [95% C.I. 8.0 - 39.7%]. The median progression free survival and the median overall survival were 3.7 and 7.5 months, respectively. The major grade 3/4 toxic effects were neutropenia (24%); anemia (24%); leucopenia (21%); anorexia (11%); fatigue (14%); hypoalbuminemia (24%); and hypokalemia (14%). One death (NOS) was considered to be related to the study. Conclusions: The results of combination Trastuzumab with irinotecan showed feasible and promising efficacy against advanced HER2-positive chemo-refractory gastric cancer. These findings indicated that trastuzumab continuation use might be beneficial. Clinical trial information: 000008626.

scholarly journals Inflammatory Markers Predict Survival in Patients With Advanced Gastric and Colorectal Cancers Receiving Anti–PD-1 Therapy

2021 ◽  
Vol 9 ◽  
Author(s):  
Xiaona Fan ◽  
Dan Wang ◽  
Wenjing Zhang ◽  
Jinshuang Liu ◽  
Chao Liu ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Overall Survival ◽  
Disease Control ◽  
Inflammatory Markers ◽  
Overall Response Rate ◽  
Response Rate ◽  
Progression Free Survival ◽  
Disease Control Rate ◽  
Free Survival ◽  
Lymphocyte Ratio

There is a lack of useful biomarkers for predicting the efficacy of anti–programmed death-1 (PD-1) therapy for advanced gastric and colorectal cancer. To address this issue, in this study we investigated the correlation between inflammatory marker expression and survival in patients with advanced gastric and colorectal cancer. Data for 111 patients with advanced gastric and colorectal cancer treated with anti–PD-1 regimens were retrospectively analyzed. Neutrophil-to-lymphocyte ratio (NLR), monocyte-to-lymphocyte ratio (MLR), platelet-to-lymphocyte ratio (PLR), and clinical characteristics of each patient were selected as the main variables. Overall response rate, disease control rate, and progression-free survival were primary endpoints, and overall survival and immune-related adverse events (irAEs) were secondary endpoints. The chi-squared test and Fisher’s exact test were used to evaluate relationships between categorical variables. Uni- and multivariate Cox regression analyses were performed, and median progression-free survival and overall survival were estimated with the Kaplan–Meier method. The overall response rate and disease control rate of anti–PD-1therapy in advanced gastric and colorectal tumors were 12.61 and 66.66%, respectively. The patients with MLR < 0.31, NLR < 5, and PLR < 135 had a significantly higher disease control rate than those with MLR > 0.31, NLR > 5, and PLR > 135 (P < 0.05). The multivariate analysis revealed that MLR < 0.31, BMI > 18.5, and anti–PD-1 therapy in first-line were associated with prolonged PFS. MLR < 0.31 and BMI > 18.5 were associated with prolonged overall survival. The irAE rate differed significantly between PLR groups, and PLR < 135 was associated with an increased rate of irAEs (P = 0.028). These results indicate that the inflammatory markers NLR, MLR, and PLR have clinical utility for predicting survival or risk of irAEs in patients with advanced gastric cancer and colorectal cancer.

Apatinib monotherapy for chemotherapy-refractory metastatic colorectal cancer: A multicenter, single-arm, prospective study.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 3527-3527 ◽  
Author(s):  
Fen Wang ◽  
Shubin Wang ◽  
Xia Yuan ◽  
Jun Jia ◽  
Xiaoxia Bi ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Overall Survival ◽  
Prospective Study ◽  
Disease Control ◽  
Metastatic Colorectal Cancer ◽  
Response Rate ◽  
Objective Response ◽  
Progression Free Survival ◽  
Disease Control Rate ◽  
Free Survival

3527 Background: Apatinib is an oral highly-selective tyrosine kinase inhibitor (TKI) that blocks vascular endothelial growth factor receptor 2 (VEGFR-2). This exploratory study evaluated the efficacy and safety of apatinib monotherapy in patients with chemotherapy-refractory metastatic colorectal cancer. Methods: In this multicenter, single-arm, prospective study, 48 patients with metastatic colorectal cancer who had failed at least two lines standard chemotherapies including fluorouracil, oxaliplatin and irinotecan were recruited from 14 centers in Guangdong, China. Apatinib at a 500mg dose was administered daily continuously. Each cycle was 4 weeks (28 days). The primary endpoint was progression free survival (PFS). Secondary end points included overall survival (OS), objective response rate (ORR), disease control rate (DCR), quality of life (QoL) and toxicity. Results: A total of 48 patients was enrolled in the study from September 3, 2015 to June9, 2017. Four patients achieved a partial response, and 22 achieved stable disease, representing a response rate of 8.3% and a disease control rate of 60.4%. Median follow-up time was 10.3 months. Median progression-free survival (PFS) and overall survival (OS) of evaluable patients (n=41) were 4.7 months (95% confidence interval [CI] 3.7-5.9) and 9.7 months (95% CI 5.9-13.6). The most common grade 3 or 4 adverse events (AE) were hypertension (12.5%), hand-foot syndrome (10.4%), thrombocytopenia (10.4%), proteinuria (8.3%) and mucositis oral (6.3%). Conclusions: Apatinib monotherapy shows promising efficacy and manageable toxicities in patients with chemotherapy-refractory metastatic colorectal cancer. Further phase 3 trial is warranted. Clinical trial information: ChiCTR1900020503.

Strahlentherapie bei Chemotherapie-refraktärem rezidivierendem Ovarialkarzinom

2015 ◽  
Vol 2 (1) ◽  
pp. 30-31
Keyword(s):  
Overall Survival ◽  
Disease Control ◽  
Response Rate ◽  
Progression Free Survival ◽  
Disease Control Rate ◽  
Palliative Behandlung ◽  
Unerwünschte Ereignisse ◽  
Free Survival ◽  
Schwerwiegende Unerwünschte Ereignisse

Ziele: Die Strahlentherapie ist als palliative Behandlung bei rezidivierendem Ovarialkarzinom gebräuchlich, jedoch wurde bisher nicht geklärt, ob sie die Prognose verbessert.Methoden: Die Wirkung einer Strahlentherapie und die damit einhergehenden unerwünschten Ereignisse bei Patientinnen mit rezidivierendem Ovarialkarzinom wurden anhand deren Patientenakten untersucht.Ergebnisse: Hierbei wurden 46 Patientinnen betrachtet: 33 Patientinnen, deren rezidivierende Läsionen auf das Bestrahlungsfeld begrenzt waren (therapeutische Bestrahlungsgruppe; TBG), und 13 Patientinnen, bei denen die rezidivierenden Läsionen zum Teil außerhalb des Bestrahlungsfelds lagen (palliative Bestrahlungsgruppe; PBG). In der TBG betrug die Ansprechrate (response rate; RR) 66%, die Rate der Krankheitsbeherrschung (disease control rate; DCR) 100%, das progressionsfreie Überleben (progression-free survival; PFS) 10 Monate und das Gesamtüberleben (overall survival; OS) 20 Monate. Das PFS nach Bestrahlung war signifikant länger als nach Bestrahlung mit unmittelbar vorausgehender Chemotherapie. Das PFS der Patientinnen mit Rezidivläsionen innerhalb des Beckens war länger als bei den Patientinnen, deren Läsionen zum Teil außerhalb des Beckens lagen. Zwischen dem PFS nach Strahlentherapie und der Dauer seit der vorhergehenden Chemotherapie oder dem histologischen Typ bestand kein signifikanter Zusammenhang. In der PBG lagen die RR bei 30%, die DCR bei 90%, das PFS bei 2 Monaten und das OS bei 6 Monaten. Schwerwiegende unerwünschte Ereignisse traten selten auf.Schlussfolgerungen: Bestrahlung ist eine mögliche Option bei Chemotherapie-refraktärem, lokal begrenztem rezidivierendem Ovarialkarzinom.Übersetzung aus Oncology 2014;86:232-238 (DOI: 10.1159/000357269)

The efficacy and safety of lenvatinib in the treatment of solid tumors: an up-to-date meta-analysis

2021 ◽  
Author(s):  
Wen jie Xie ◽  
Shuai Zhang ◽  
Lei Su ◽  
Yan hong Li ◽  
Xi Zhang ◽  
...  
Keyword(s):  
Overall Survival ◽  
Overall Response Rate ◽  
Response Rate ◽  
Meta Analysis ◽  
Severe Infection ◽  
Progression Free Survival ◽  
Hazard Ratio ◽  
Efficacy And Safety ◽  
Free Survival ◽  
Overall Response

Aim: We performed an updated meta-analysis to evaluate the efficacy and safety of lenvatinib in cancer patients. Materials & methods: Databases were searched to identify relevant trials. Data were extracted to evaluate overall survival, progression-free survival, overall response rate and grade ≥3 adverse events. Results: The pooled analysis demonstrated that lenvatinib significantly improved progression-free survival (hazard ratio: 0.43; 95% CI: 0.23–0.80; p = 0.008), overall survival (hazard ratio: 0.85; 95% CI: 0.75–0.97; p = 0.013) and overall response rate (relative risk: 6.89; 95% CI: 2.22–21.36; p = 0.001) compared with control therapy. However, the use of lenvatinib can increase the risk of severe infection. Conclusion: Lenvatinib-containing regimens are associated with better progression-free survival, overall survival and overall response rate, but can induce severe infection.

A phase ll study of new combination regimen with trastuzumab, S-1, and CDDP in HER2-positive advanced gastric cancer (HERBIS-1).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 4072-4072
Author(s):  
Keisuke Koeda ◽  
Naotoshi Sugimoto ◽  
Junji Tanaka ◽  
Masahiro Tsuda ◽  
Wataru Okamoto ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Overall Survival ◽  
Advanced Gastric Cancer ◽  
Response Rate ◽  
Progression Free Survival ◽  
New Combination ◽  
Combination Regimen ◽  
Her2 Positive ◽  
Threshold Response ◽  
Grade 3

4072 Background: S-1, a novel oral fluoropyrimidine, plus cisplatin (SP) regimen is one of the standard chemotherapy as first-line for advanced gastric cancer. ToGA study demonstrated that trastuzumab (T-mab) combination regimen improved the overall survival of patients with HER2-positive advanced gastric cancer. However, there was no study evaluating the efficacy and the safety of T-mab in combination with S-1 plus cisplatin (SP) regimen. Therefore, we planned this study to examine the efficacy and the safety of the SP plus T-mab. Methods: Patients confirmed to be HER2-positive by IHC and/or FISH (IHC 3+ or IHC 2+ and FISH positive) received S-1 at 80 mg/m2 po, day 1-14, and cisplatin 60 mg/m2 iv, day 1 plus trastuzumab 8 mg/kg iv, day 1 (6 mg/kg iv, d1 from 2nd course), repeated every 3 weeks until disease progression. Primary endpoint was response rate (RR). Secondary endpoints were progression-free survival, overall survival and safety. The threshold response rate was defined as 35%, and the expected rate was set at 50% with a 80% power and a 1-sided alpha value of 0.1 and the calculated sample size was 50 patients. Results: A total of 56 patients (median age 66) were enrolled in this study. The efficacy and the safety analyses were conducted in the full analysis set of 53 patients. (Two patients were excluded for ineligibility and one was for no treatment). The confirmed RR assessed by the independent review committee was 67.9% (95% CI: 53.7 – 80.1), and the disease control rate was 94.3%. The median PFS was 7.1 months (95% CI: 6.0 – 10.1). The median OS was not reached. (The median follow-up time: 9.2 months) The main grade 3/4 adverse events were as follows: neutropenia 34%, leucopenia 8%, anorexia 23%, diarrhea 8%, hypoalbuminemia 4%, vomiting 6%, and increased creatinine 6%. Conclusions: This tri-week regimen with SP plus T-mab showed promising results in patients with HER2-positive advanced gastric cancer. Clinical trial information: UMIN000005739.

scholarly journals Apatinib, a novel VEGFR-2 tyrosine kinase inhibitor, for relapsed and refractory nasopharyngeal carcinoma: data from an open-label, single-arm, exploratory study

2020 ◽  
Vol 38 (6) ◽  
pp. 1847-1853
Author(s):  
Ling Li ◽  
Fei Kong ◽  
Lei Zhang ◽  
Xin Li ◽  
Xiaorui Fu ◽  
...  
Keyword(s):  
Overall Survival ◽  
Nasopharyngeal Carcinoma ◽  
Adverse Events ◽  
Overall Response Rate ◽  
Response Rate ◽  
Kinase Inhibitor ◽  
Progression Free Survival ◽  
Efficacy And Safety ◽  
Open Label ◽  
Free Survival

Summary Purpose Apatinib, a new tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor-2, has shown promising efficacy against several solid cancers, but evidence of its efficacy against relapsed and refractory nasopharyngeal carcinoma is limited. We investigated the efficacy and safety of apatinib for relapsed and refractory nasopharyngeal carcinoma in an open-label, single-arm, phase II clinical trial. Fifty-one patients with relapsed and refractory nasopharyngeal carcinoma in the First Affiliated Hospital, Zhengzhou University, who met the inclusion criteria were enrolled in the study. All patients received apatinib at an initial dose of 500 mg daily (1 cycle = 28 days). The primary and secondary endpoints were overall response rate, progression-free survival, and overall survival. We evaluated treatment effects and recorded apatinib-related adverse events by performing regular follow-ups and workup. The overall response rate (complete and partial responses) was 31.37% (16/51). The median overall survival and progression-free survival were 16 (95% CI, 9.32–22.68) and 9 months (95% CI, 5.24–12.76), respectively. Most patients tolerated treatment-related adverse events of grades 1 and 2; hypertension (29, 56.86%), proteinuria (25, 49.02%), and hand–foot syndrome (27, 52.94%) were the most common adverse events. There were no treatment-related deaths. Apatinib showed good efficacy and safety in patients with relapsed and refractory NPC.

Đánh giá kết quả hóa trị triệu chứng bước 1 ở bệnh nhân ung thư dạ dày giai đoạn tiến xa bằng phác đồ có epirubicin, oxaliplatin, capecitabin

2020 ◽  
Author(s):  
Hong Chuyen Nguyen Thi
Keyword(s):  
Gastric Cancer ◽  
Overall Survival ◽  
Cancer Patients ◽  
Response Rate ◽  
Progression Free Survival ◽  
Advanced Stage ◽  
First Line ◽  
Free Survival ◽  
Gastric Cancer Patients ◽  
Line Chemotherapy

Purpose:to study clinical and subclinical characteristics in advanced stage gastric cancer patients and to evaluate response rate, overall survival, progression free survival and toxicities on advanced stage gastric cancer patients treated with first line chemotherapy using epirubicin, oxaliplatin, capecitabin Methods: A retrospective case series study with 134 advanced stage gastric cancer patients on first line chemotherapy using epirubicin, oxaliplatin, capecitabin recruited from oncology department, the Hospital of Hue University of Medicine and Pharmacy and Cancer Center at Hue Central Hospital during January 2015 to June 2019. Results: Patient’s mean age was 54,9; men/women was 2,52/1. The most frequent clinical symptom reported was epigastric pain 81,3%. KPS 80-90% presented in almost patient (93.3%). The most common site of cancer was pyloric antrum (61,9%). 58,2% patients had distant metastasis disease which liver was the most frequent site. The overall response rate, partial response rate, complete response rate were 49,2%, 42,5%, 6,7% respectively. The median progression free survival was 8,6 ± 0,15 months and the overall survival was 10,7 ± 1,1 months. The pathologic type and combined salvage surgery status were response correlated factors. Grade 3, 4 toxicities in term of hematology, liver and kidney function were only exhibited in a few cases. Patients were tolerated well with chemotherapy. No deaths related to chemotherapy. Conclusions: This study shows that EOX regimen was safe and effective. As a results, we can apply this for first line pallative chemotherapy on advanced stage gastric cancer which KPS ≥70%.

The impact of dose reduction and time delay in irinotecan- and oxaliplatin-based chemotherapies on outcomes in metastatic colorectal cancer.

2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 631-631
Author(s):  
Naoki Mashita ◽  
Goro Nakayama ◽  
Naomi Hayashi ◽  
Chie Tanaka ◽  
Daisuke Kobayashi ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Time Delay ◽  
Disease Control ◽  
Metastatic Colorectal Cancer ◽  
Total Dose ◽  
Dose Reduction ◽  
Response Rate ◽  
Progression Free Survival ◽  
Disease Control Rate ◽  
Free Survival

631 Background: This study was designed to evaluate the influence of dose reduction and schedule modification on outcomes in patients with metastatic colorectal cancer (mCRC). Methods: Pooled datasets from two previous phase II trials of FOLFIRI (CCOG-0502; n = 36) and mFOLFOX6 (CCOG-0704; n = 30) in patients with mCRC were analyzed retrospectively. The RDIs of irinotecan and oxaliplatin were compared to response rate (RR), disease control rate (DCR), progression-free survival (PFS) and overall survival (OS). To assess the effects of dose reduction and time delay, we defined ‘dose index (DI)’ as the ratio of the actual delivered total dose to the planned total dose and ‘time index (TI)’ as the ratio of the planned duration to the actual duration of therapy. Relative dose intensity (RDI) was computed by multiplying DI by TI. DI and TI of irinotecan and oxaliplatin were compared to response rate (RR), disease control rate (DCR) and progression-free survival (PFS). Results: In patients receiving FOLFIRI therapy, the median DI and TI of irinotecan were 0.92 and 0.90, respectively. RRs were 59% vs. 12% in the higher vs. lower DI groups (p < 0.01), and 35% vs. 35% in the higher vs. lower TI groups (p = 1.00), respectively. Median PFS was 10.2 vs. 5.0 months in the higher vs. lower DI groups (p < 0.01), and 6.1 vs. 6.7 months in the higher vs. lower TI groups (p = 0.48), respectively. In mFOLFOX6 therapy, the median DI and TI of oxaliplatin were 0.97 and 0.82, respectively. RRs were 44% vs. 36% in the higher vs. lower DI groups (p = 0.65), and 44% vs. 36% in the higher vs. lower TI groups (p = 0.65), respectively. Median PFS was 7.7 vs. 6.7 months in the higher vs. lower DI groups (p = 0.13), and 8.5 vs. 5.9 months in the higher vs. lower TI groups (p = 0.02), respectively. Multivariate analyses showed that DI of irinotecan (HR 8.48; 95% CI, 2.94-24.51, p < 0.01) and TI of oxaliplatin (HR 2.74; 95% CI, 1.02-7.33, p = 0.04) were the independent prognostic factors for PFS. Conclusions: Dose reductions in irinotecan and time delays in oxaliplatin could have significant impact on PFS in patients receiving FOLFIRI and FOLFOX6, respectively.

Efficacy and safety of FOLFIRI regimen in elderly versus nonelderly patients with advanced colorectal and gastric cancer.

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 701-701
Author(s):  
Jin Won Kim ◽  
Kyu-Pyo Kim ◽  
Ju Hyun Lee ◽  
Yong Sang Hong ◽  
Sun Young Kim ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Response Rate ◽  
Age Groups ◽  
Dose Intensity ◽  
Progression Free Survival ◽  
Efficacy And Safety ◽  
Elderly Age ◽  
Free Survival ◽  
Grade 3 ◽  
Two Age Groups

701 Background: Irinotecan-based chemotherapy is a standard backbone in patients (pts) with advanced colorectal (CRC) or gastric cancer (GC). However, there is still a paucity of information concerning the efficacy and safety of irinotecan-based regimen in elderly pts. Methods: Using pt cohort (N = 1,545) of the UGT1A1 genotype study (Kim KP, et al. J Clin Oncol 33, 2015 (suppl; abstr 3600)), we performed subgroup analysis comparing the efficacy and safety between elderly (age ≥ 70 years, median 73 years, N = 245) and non-elderly ( < 70 years, median 57 years, N = 1,300) pts with advanced CRC or GC who received first- or second-line FOLFIRI chemotherapy. Results: In both CRC (N = 934) and GC cohorts (N = 611), elderly pts received significantly lower dose of irinotecan (CRC: mean 74.8% vs. 80.9%, P < 0.001; GC: 72.4% vs. 76.2%, P = 0.018) and infusional 5-fluorouracil (CRC: 61.6% vs. 71.8%, P < 0.001; GC: 47.1% vs. 55.8%, P = 0.004). However, the response rate was similar between elderly and non-elderly pts in both CRC (28.7% vs. 32.9%, P = 0.347) and GC cohorts (22.9% vs. 18.3%; P = 0.369). The progression-free survival was also similar between the two age groups in both CRC (median 27.9 vs. 29.1 weeks, P = 0.202) and GC cohorts (20.1 vs. 17.0 weeks, P = 0.407). In addition, the overall survival was comparable between the two age groups in both CRC (81.9 vs. 91.8 weeks, P = 0.965) and GC cohorts (33.6 vs. 49.3 weeks, P = 0.085). In both cohorts, asthenia was significantly more frequent in elderly pts, while nausea and vomiting were significantly more frequent in non-elderly pts. In CRC cohort, grade 3-4 toxicities that were significantly more frequent in elderly pts were asthenia (1.3% vs. 0.2% per cycle, P < 0.001), mucositis (0.4% vs. 0.1%, P = 0.021), and anorexia (0.8% vs. 0.2%, P = 0.005) in CRC cohort. However, in GC cohort, grade 3-4 toxicities were not significantly different between the two age groups. Conclusions: Despite relatively lower dose intensity in elderly pts, efficacy of FOLFIRI regimen in this subset was comparable to that of non-elderly pts. FOLFIRI regimen was relatively well tolerated in elderly pts. Taken together, FOLFIRI is a considerable standard backbone in elderly pts with advanced CRC or GC.

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