The comparison of the usefulness of nab-paclitaxel and paclitaxel for advanced or recurrent gastric cancer.

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 217-217
Author(s):  
Yasue Kimura ◽  
Tetsuya Kusumoto ◽  
Eiji Kusumoto ◽  
Masahiko Sugiyama ◽  
Mitsuhiko Ohta ◽  
...  

217 Background: For patients who do not respond to S-1-based treatment in Japan, weekly paclitaxel (PTX) therapy is more frequently used as second-line chemotherapy. On the other hand, the agent could not be used for alcohol hypersensitivity in some cases. Nab-Paclitaxel (N-PTX), which is the protein-bound paclitaxel, has recently been introduced in Japan. The purpose of this study was to retrospectively determine the more preferable agent, N-PTX or PTX, following the S-1-containing chemotherapy in patients with advanced or recurrent gastric cancer (ARGC). Methods: We conducted a retrospective review of the data for 40 patients with ARGC, who received either N-PTX monotherapy for 5 patients or PTX monotherapy for 35 patients. N-PTX was used as the second-line for all patients in this group. On the other hand, in the PTX group, 4, 28 and 3 patients received PTX monotherapy as the 1st-, 2nd- and 3rd-line, respectively. N-PTX was administered intravenously at a dose of 260 mg/m2 repeated triweekly. PTX was administered intravenously at a dose of 80 mg/m2repeated weekly (on days 1, 8 and 15) every four weeks. The objective response rate (ORR), adverse events, progression-free survival (PFS) were compared between the two groups. Results: For tumor response, in the N-PTX group, CR/PR/SD/PD were 0/3/1/1, respectively for an ORR of 60% and a DCR of 80%; in the PTX group, CR/PR/SD/PD were 0/3/15/13, respectively for an ORR of 10% and a DCR of 58%. The ORR of the N-PTX group was higher, which might result from the higher dose intensity in the group, compared with the PTX group. For the adverse toxicity, in the both group, events of grade ≥ 3 were not observed. Serious neurotoxicity (≥grade 3), as commonly described for treatment with paclitaxel, was not observed in this study. The survival data showed that the PFS was 253 days in the N-PTX group, compared with 176 days in the PTX group, which were not significantly different. Conclusions: We suggest the application of N-PTX in place of PTX after S-1 containing chemotherapy for ARGC, only from the perspective of the tumor response. Further data accumulation is required for overall survival.

2017 ◽  
Vol 35 (4_suppl) ◽  
pp. 91-91
Author(s):  
Yoshinari Mochizuki ◽  
Daisuke Kobayashi ◽  
Hiroshi Kojima ◽  
Hiroshi Nakayama ◽  
Yoshihisa Kawase ◽  
...  

91 Background: Nab-paclitaxel (nab-PTX) is a candidate as second-line chemotherapy for gastric cancer, with the response rate (RR) of 28% and overall survival (OS) of 9.2 months in that setting in Japan (J-0200). Adverse events (AE) of grade 3 or more were frequent and included neutropenia in 49%, leucopenia in 20% and peripheral nerve disorder (PND) in 24%. Modified dose reduction criteria to manipulate the doses earlier might be more practical, given the relative dose intensity (RDI) of paclitaxel (PTX) in the conventional weekly regimen. Phase II prospective trial was conducted to explore the efficacy and safety of nab-PTX with modified dose reduction criteria. Methods: Patients with histologically confirmed metastatic or recurrent gastric adenocarcinoma that progressed during the fluoropyrimidine-containing first-line chemotherapy were eligible. Patients pretreated with PTX were excluded. Nab-PTX (260 mg/m2) was administered triweekly. Dose reduction was regulated according to predefined toxicity criteria which included neutropenia < 1000/mm3 and/or PND with grade 2 or more. Treatment was to be continued until PD, unacceptable toxicity, or patient’s refusal. The primary endpoint was progression free survival (PFS). Secondary endpoints were OS, RR and toxicity. Results: A total of 50 patients were enrolled from 14 institutions, 47 of whom were eligible for efficacy analyses. The median number of treatment given was 4 cycles (range, 1-25). Of total administration throughout the trial of 280 cycles, dose reduction was needed in 52 cycles (22%). The RDI was 80%. The median PFS was 3.5 months (range, 0.4-20.2) that was equivalent to the expected value designed in the study. The median OS was 9.0 months (range, 1.4-22.1) and RR was 16% (95%CI 2-30). AE of grade 3 or more included neutropenia in 49%, leucopenia in 21% and PND in 11%. Febrile neutropenia occurred in 1 patient (2%). The median time to treatment failure was 3.5 months (range, 0.4-18.0). Conclusions: The modified dose reduction criteria for triweekly administration of nab-PTX resulted in decreased incidence of severe PND without fall in efficacy. Clinical trial information: UMIN000012247.


2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e15173-e15173
Author(s):  
Tetsuya Kusumoto ◽  
Koji Ando ◽  
Satoshi Ida ◽  
Yasue Kimura ◽  
Hiroshi Saeki ◽  
...  

e15173 Background: S-1 monotherapy or S-1/CDDP have remained important as a standard chemotherapy regimen for patients with advanced gastric cancer (AGC), based on the randomized phase III trials. Although S-1/docetaxel has been reported highly active and well tolerated for AGC by many researchers, it could not show the superiority compared with S-1 monotherapy in the recent international randomized trial. We have also demonstrated that it might be effective for patients with Stage III AGC in both preoperative and postoperative adjuvant setting. The aim of this study was to evaluate efficacy, toxicity and validity of S-1/docetaxel retrospectively, compared with the standard regimens. Methods: We conducted a retrospective review of the data of 89 patients with AGC who received chemotherapy who were given S-1-containing regimens as the first line chemotherapy; 15 patients treated with S-1 monotherapy, 21 with S-1/CDDP, and 53 with S-1/docetaxel. The objective response, adverse event (AE), progression-free survival (PFS), and overall survival (OS) were compared between the three groups. Results: The overall response rates (ORRs) were obtained 6.7%, 38.1% and 30.2% for S-1 monotherapy, S-1/CDDP, and S-1/docetaxel, respectively. The incidence of AEs was more frequent in S-1 based combined treatments than in the S-1 monotherapy, however there was no significant difference in the severe AEs between each group. Survival data showed that the PFSs were 121 days, 199 days and 178 days, respectively, and there was the significant difference between S-1 monotherapy and S-1/docetaxel (p<0.05). The overall survival showed that the MSTs were not significantly different. The conversion rate to the subsequent treatments following S-1 monotherapy was higher than the other treatments. Conclusions: S-1/docetaxel was active and well tolerated for the patients with ARGC as the first line. Although the Japanese guideline for treatment of gastric cancer recommends S-1 monotherapy or S-1/CDDP as the standard regimens, docetaxel could be applied for patients with AGC in case of CDDP-resistant or –naïve patients.


2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 15052-15052
Author(s):  
S. Cho ◽  
H. Shim ◽  
S. Lee ◽  
J. Ahn ◽  
D. Yang ◽  
...  

15052 Background: Taxane has been used widely in advanced gastric cancer, but toxicities are problematic. To avoid the bone marrow suppression, docetaxel could be replaced paclitaxel to reduce bone marrow suppression and to improve the efficacy, we planned to augmentation of the dose intensity. This phase II study evaluated the efficacy and safety of combination chemotherapy with paclitaxel, cisplatin, and 5-fluorouracil (5-FU) in advanced gastric cancer. Methods: Patients with histologically confirmed gastric adenocarcinoma, ECOG PS = 2, at least one measurable lesion and adequate organ functions were eligible. Paclitaxel (175 mg/m2) and cisplatin (75 mg/m2) were given as a 1-h intravenous infusion on day 1, followed by 5-FU (750 mg/m2) as a 24-h continuous infusion for 5 days. This cycle was repeated every 3 weeks. Results: Forty-five eligible patients (median age 56 years) were treated in this way. Of the 41 patients in whom efficacy was evaluable, an objective response rate (ORR) was seen in 20 (48.8%), a complete response in two, and a partial response in 18 patients. The median time to progression was 6.9 months (95% CI, 5.86–7.94), and the median overall survival was 13.1 months (95% CI, 8.83–17.37). The main hematological toxicity was neutropenia and greater than grade 3 neutropenia was observed in 67 cycles (25%). Febrile neutropenia developed in three patients (7.3%). The major non-hematological toxicities were asthenia and peripheral neuropathy, but grade 3 or 4 toxicity was not seen. Conclusions: The combination chemotherapy with paclitaxel, cisplatin, and 5-FU is a promising regimen, and was well tolerated in patients with advanced gastric cancer. No significant financial relationships to disclose.


2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e14722-e14722
Author(s):  
Tetsuya Kusumoto ◽  
Eiji Oki ◽  
Shoji Hiroshige ◽  
Kenkichi Hashimoto ◽  
Kousuke Suzuki ◽  
...  

e14722 Background: S-1 is effective and clinically important agent in the initial chemotherapy against advanced or recurrent gastric cancer (ARGC) in Asia. Although several prospective studies on the second-line chemotherapy for ARGC are currently in progress in Japan, the sufficient investigation on the proposition has not been made. We assessed here the clinical efficacy of irinotecan (CPT-11) and paclitaxel (PTX) as the second or thirdline chemotherapeutic agents following the S-1 based treatment, as those has been frequently used in practice. Methods: We conducted the retrospective review of the data of 30 patients with unresectable ARGC who received CPT-11 or PTX monotherapy after administration of S-1 as prior treatment. Each 15 patients were given chemotherapy including CPT-11 and PTX monotherapy treatments, after S-1 containing regimens, as second or third line treatments. The objective response, adverse events, progression-free survival (PFS), and overall survival (OS) were compared between CPT-11 and PTX monotherapy groups. Results: The similar data of the overall response rates (ORRs) were obtained between two groups. Survival data showed that the MST was 329 days and the median PFS was 220 days for the administration of CPT-11, compared with 297 days and 132 days in PTX group from the beginning of these drugs administration, were not significantly different. The OS was 707 days in CPT-11 group, compared with 751 days in PTX group, were not significantly different. Conclusions: There is no order of priority of regimens including CPT-11 or PTX after S-1 containing chemotherapy treatments. We believe that both awareness of the next line chemotherapy and the selection of drugs were important of survival prolongation for patients with ARGC.


2021 ◽  
Vol 11 ◽  
Author(s):  
Caiyun Nie ◽  
Huifang Lv ◽  
Yingjun Liu ◽  
Beibei Chen ◽  
Weifeng Xu ◽  
...  

BackgroundThe present study was conducted to analyze the clinical efficacy and safety of sintilimab as second-line or above therapy for patients with advanced or metastatic gastric cancer.MethodsPatients with advanced or metastatic gastric cancer that progressed after prior systemic therapies and treated with sintilimab from March 2019 to July 2020 were retrospectively analyzed in this study. The primary end point was progression-free survival (PFS). Secondary end points included objective response rate (ORR), disease control rate (DCR), overall survival (OS), and safety.ResultsFifty-two patients with advanced or metastatic gastric cancer received sintilimab monotherapy or combination therapy after they failed from prior systemic therapies. Eight patients achieved partial response (PR), 26 patients had stable disease (SD), and 18 patients had progressive disease (PD). The ORR and DCR were 15.4% (8/52) and 65.4% (34/52), respectively. Median PFS was 2.5 months (95% CI = 2.0–3.0), and median OS was 5.8 months (95% CI = 4.9–6.7). The ORR and DCR were 30.0% (6/20) and 80.0% (16/20), respectively, in intestinal subtype, which were superior than in non-intestinal subtype (ORR: 6.3%, DCR: 56.3%). Patients with intestinal subtype obtained longer PFS (4.0 vs. 1.9) and OS (9.0 vs. 4.1) than those with non-intestinal subtype. The incidence of grade 3–4 adverse events was 44.2%.ConclusionsSintilimab monotherapy or combination therapy provides a feasible therapeutic strategy for patients with advanced or metastatic gastric cancer who failed from prior systemic therapies. The efficacy of sintilimab in intestinal subtype was superior than that in non-intestinal subtype.


2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 90-90 ◽  
Author(s):  
Hiroya Takiuchi ◽  
Yasutsuna Sasaki ◽  
Tomohiro Nishina ◽  
Hirofumi Yasui ◽  
Kei Muro ◽  
...  

90 Background: ABI-007 is a novel Cremophor-free nanoparticle albumin-bound paclitaxel. Cremophor-free formulation allows administration using a shorter infusion schedule (30 minutes) and without the need for premedicaion to prevent solvent-based hypersensitivity reactions.This single arm phase II study evaluated the efficacy and safety of ABI-007 given every three weeks to unresectable or recurrent gastric cancer patients (pts) who had received one prior chemotherapy regimen containing fluoropyrimidine and developed disease progression (PD) or recurrence. Methods: Eligibility include: histologically or cytologically confirmed gastric adenocarcinoma , received one prior regimen containing fluoropyrimidine analogs and developed PD or recurrence, age: 20 - 74, at least one measurable lesion by RECIST(1.0), PS:0-2, adequate organ function and written informed consent. Study duration was until PD or unacceptable toxicity developed. Pts received ABI-007 260 mg/m2, i.v. on day 1 of each 21 day cycle) without premedication. The primary endpoint was overall objective response rate (ORR). Results: From April 2008 to July 2010, total of 56 pts were enrolled, 55 received the study treatment, and 54 pts were evaluable for response. Median age was 64, Male/Female was 43/12, PS:0/1/2 was 33/22/0 and number of sites of metastasis corresponding was 1/2/≥3:19/21/15. ORR was 27.8% (15/54; 95%CI, 16.5-41.6) and DCR (disease control rate:CR+PR+SD) was 59.3% (32/54, 95%CI, 45.0-72.4) for all evaluable patients. One confirmed CR was observed. Median progression–free survival was 2.9 months (95%CI, 2.4-3.6), and median overall survival was 9.0 months (95%CI, 6.6-11.5). The most common grade 3/4 toxicities were neutropenia (49.1%), leucopenia (20.0%), lymphopenia (10.9%); and peripheral sensory neuropathy (23.6%). Conclusions: These data demonstrate that ABI-007 showed promising activity with well-tolerated toxicities for previously treated unresectable or recurrent gastric cancer pts.


2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 205-205
Author(s):  
Daisuke Takahari ◽  
Manabu Ohashi ◽  
Atsuo Takashima ◽  
Takuro Mizukami ◽  
Naoki Ishizuka ◽  
...  

205 Background:TAS-118 (S-1 and leucovorin) + oxaliplatin (L-OHP) improved overall survival (OS) compared to S-1 + cisplatin for patients (pts) with advanced gastric cancer (GC) (Kang, Lancet Oncol. 2020). This study investigated the feasibility of peri (pre and post)-operative (op) chemotherapy (chemo) with TAS-118 ± L-OHP in pts with locally advanced resectable GC. While it was reported that pre-op TAS-118 + L-OHP followed by D2 gastrectomy was well tolerated and showed promising efficay (Takahari, ASCO-GI. 2020), the recommended post-op chemo regimen, TAS-118 or TAS-118 + L-OHP, has yet to be determined. Methods:Eligible pts with GC of clinical T3-4N1-3M0 were enrolled. The protocol treatment consisted of pre-op chemo with 4 courses of TAS-118 (40-60 mg/body, orally, twice daily, 7 days) + L-OHP (85 mg/m2, intravenously, day 1) in a 2-week cycle, and gastrectomy with D2 lymphadenectomy, followed by post-op chemo with 12 courses of TAS-118 (step 1) and 8 courses of TAS-118 + L-OHP (step 2). Step 2 was started if the dose-limiting toxicity (DLT) occurred in < 6 of 10 pts in step 1. Up to 20 pts were included in the analysis of feasibility after a recommended regimen was determined. Results:Between December 2016 and February 2019, 45 pts were enrolled. The numbers of pts with cT3/4a and cN1/2/3 were 13/32 and 25/17/3, respectively. Excluding 14 pts (4 achieving pathological complete response, 4 not satisfying the criteria for post-op chemo, 3 physician judgement or pt withdrawal, 2 progressive disease, 1 adverse event [AE]), 31 pts (11/20 in step 1/2) received the post-op chemo. No DLT was observed in either step. The post-op chemo completion rate was 90.9% (95% CI, 63.6-99.5) in step 1 and 80.0% (95% CI, 59.9-92.9) in step 2. The median relative dose intensity of TAS-118 in step 1 was 83.3%, and those of TAS-118 and L-OHP in step 2 were 69.9% and 74.3%, respectively. One pt in step 2 discontinued post-op chemo due to AE. Grade ³ 3 AEs observed in ≥ 10% of pts were weight loss in both step 1 and step 2 (2 in each), and hypokalemia (n = 3) and neutropenia (n = 2) in step 2. At 1-year follow-up after the last pt was enrolled, recurrence-free survival and OS rates were 91.1% (95% CI, 78.0-96.6) and 100%, respectively at 12 months, and 69.1% (95% CI, 49.6-82.3) and 95.5% (95% CI, 71.9-99.3), respectively at 24 months. Conclusions:Taken together with the feasibility and efficacy of pre-op chemo, peri-op chemo with TAS-118 + L-OHP with D2 gastrectomy was well tolerated and showed promising efficacy. Clinical trial information: UMIN000024688.


2006 ◽  
Vol 9 (1) ◽  
pp. 14-18 ◽  
Author(s):  
Shuichi Hironaka ◽  
Sadamoto Zenda ◽  
Narikazu Boku ◽  
Akira Fukutomi ◽  
Takayuki Yoshino ◽  
...  

2021 ◽  
Author(s):  
Lei Han ◽  
Li Li ◽  
Jinli Hao ◽  
Yuanli Lu ◽  
Shicheng Li ◽  
...  

Abstract Introduction: This study is aimed to evaluate the efficacy and safety of sintilimab combined with albumin-bound paclitaxel/ cisplatin as a second-line treatment in these patients with relapsed or refractory extensive-stage small cell lung cancer (ES-SCLC). Methods and Materials: ES-SCLC patients received a second-line regimen of sintilimab combined with albumin-bound paclitaxel/cisplatin. Albumin-bound paclitaxel/cisplatin can be used for up to 6 cycles. Sintilimab use was not stopped until the disease progressed or untolerable side effects occurred. After 2 cycles of chemotherapy or when the patient's condition progressed significantly, computed tomography was rechecked to observe the clinical curative effect and adverse reactions. Results: Totally 38 patients with recurrent SCLC were included for efficacy evaluation. The objective response rate and disease control rate were 26.3% and 84.2% respectively. The median PFS and OS were 6.5 months (95% CI: 3.8-7.8) and 10.8 months (95% CI: 8.5-16.2), respectively. The main adverse reactions are bone marrow suppression, alopecia, peripheral neurotoxicity, muscle and joint pain, gastrointestinal reactions, and fatigue. The severe adverse reactions (grade 3-4) are mainly leukopenia (21.1%), neutropenia (21.1%) and decreased hemoglobin (7.9%). No significant correlation was found between PD-L1 expression and efficacy.Conclusion: Sintilimab combined with albumin-bound paclitaxel/cisplatin has a positive effect on the treatment of ES-SCLC, and the adverse reactions are tolerable.


2016 ◽  
Vol 2016 ◽  
pp. 1-6 ◽  
Author(s):  
Joo Young Jung ◽  
Min-Hee Ryu ◽  
Baek-Yeol Ryoo ◽  
Boram Han ◽  
Ji Woong Cho ◽  
...  

Background.This retrospective study aimed to assess the efficacy and toxicities of second-line chemotherapy with irinotecan, leucovorin, and 5-fluorouracil (5-FU) in metastatic gastric cancer (MGC) patients previously treated with docetaxel and S-1 with or without oxaliplatin (DS/DOS).Patients and Methods.We reviewed the data of patients who had previously been treated with first-line DS/DOS and received biweekly irinotecan-based chemotherapy (FOLFIRI/IFL) between October 2004 and November 2011.Results.A total of 209 cycles were administered to 35 patients, with a median of 4 (range, 1–22) cycles each. The overall response rate in 29 response-assessable patients was 17.2%, including 2 complete and 3 partial responses. The median progression-free and overall survivals were 3.81 (95% confidence interval [CI], 1.82–5.80) months and 6.24 (95% CI, 1.44–11.04) months, respectively. The major grade 3/4 toxicity was neutropenia (8.6%).Conclusion.FOLFIRI/IFL chemotherapy showed modest antitumour activity and tolerable toxicities in DS/DOS-treated MGC patients.


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