Performance status as prognostic factor in phase III trials of first‐line chemotherapy of unresectable or metastatic pancreatic cancer: A trial‐level meta‐analysis

2021 ◽  
Author(s):  
Giuseppe Colloca
Keyword(s):  
Pancreatic Cancer ◽  
Prognostic Factor ◽  
Meta Analysis ◽  
Performance Status ◽  
Phase Iii ◽  
Metastatic Pancreatic Cancer ◽  
First Line ◽  
Phase Iii Trials ◽  
Line Chemotherapy

Efficacy of S-1 compared to modified FOLFIRINOX as second-line chemotherapy regimens after gemcitabine plus nab-paclitaxel for patients with metastatic pancreatic cancer.

2017 ◽  
Vol 35 (4_suppl) ◽  
pp. 449-449 ◽  
Author(s):  
Gen Kimura ◽  
Hideaki Takahashi ◽  
Kumiko Umemoto ◽  
Kazuo Watanabe ◽  
Mitsuhito Sasaki ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Chemotherapy Regimen ◽  
Phase Iii ◽  
Metastatic Pancreatic Cancer ◽  
Line Treatment ◽  
Second Line ◽  
First Line ◽  
Second Line Chemotherapy ◽  
Clinical Records ◽  
Line Chemotherapy

449 Background: Recently, gemcitabine (GEM) plus nab-paclitaxel (nab-PTX) has been frequently used as a first-line chemotherapy regimen for the treatment of metastatic pancreatic cancer (mPC) in Japan. Nanoliposomal irinotecan combined with 5-fluorouracil and leucovorin (MM-398 plus 5FU/LV) has not yet been approved in Japan. Under these circumstances, a modified FOLFIRINOX (mFFX) regimen or S-1 is commonly used as a second-line chemotherapy regimen for patients with mPC after GEM plus nab-PTX has failed. Methods: Between December 2014 and March 2016, 45 patients with mPC received second-line chemotherapy after the failure of GEM plus nab-PTX (standard dose regimen) at the National Cancer Center Hospital East. Twenty-two patients received mFFX (irinotecan, 150 mg/m2; bolus of 5FU was eliminated), 19 received S-1 (80 mg/m2/d; d1-28, q6w or d1-14, q3w), and 4 received other chemotherapy regimens. The clinical records of the patients were reviewed retrospectively. Results: At baseline, S-1 group had a more severe disease status than the mFFX group (performance status of 0: 21% vs. 68%, P = 0.003; median CA19-9 level: 1832 vs. 577 U/mL, P = 0.30). No significant difference in the response rate (S-1, 5.3% vs. mFFX, 9.1%, P = 0.56) or the disease control rate (S-1, 42% vs. mFFX, 36%, P = 0.71) was seen between the two groups. The progression free survival (PFS) (median: S-1 vs. mFFX: 2.7 vs. 2.4 months (m), P = 0.77), the overall survival (OS) from the second-line treatment (median: 6.1 vs. 6.4m, P = 0.87) and the OS from the first-line treatment (median: 10.9 vs. 12.4m, P = 0.77) were not significantly different between the two groups. These results were similar to those observed for MM-398 plus 5FU/LV (PFS, 3.1m; OS, 6.1m) in a pivotal Phase III study (NAPOLI-1). The incidences of peripheral neuropathy (5.3% vs. 32%, P = 0.04), fatigue (11% vs. 50%, P = 0.007), and neutropenia (11% vs. 64%, P = 0.001) were significantly lower in the S-1 group. Conclusions: S-1 was less toxic than mFFX and exerted a similar anti-tumor effect in the present study. S-1 could be a treatment option for patients with mPC refractory to GEM plus nab-PTX.

Clinical outcome of modified FOLFIRINOX versus gemcitabine plus nab-paclitaxel as first line chemotherapy in metastatic pancreatic cancer.

2017 ◽  
Vol 35 (4_suppl) ◽  
pp. 438-438 ◽  
Author(s):  
Kazuo Watanabe ◽  
Yusuke Hashimoto ◽  
Kumiko Umemoto ◽  
Hideaki Takahashi ◽  
Mitsuhito Sasaki ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Febrile Neutropenia ◽  
Adverse Events ◽  
Performance Status ◽  
Objective Response ◽  
Metastatic Pancreatic Cancer ◽  
Cancer Center ◽  
First Line ◽  
Ecog Performance Status ◽  
Line Chemotherapy

438 Background: FOLFIRINOX and Gemcitabine plus nab-paclitaxel (GN) have been established as first line chemotherapy in metastatic pancreatic cancer (mPC). But few data support preferable first line choice of these two regimens in “real-world” clinical setting. Methods: We retrospectively enrolled 135 chemotherapy-naive mPC patients treated with modified FOLFIRINOX (mFFX) or GN at National Cancer Center Hospital East between December 2013 and September 2015. mFFX is a modified regimen of reduced dose of irinotecan 150mg/m2 and eliminated bolus 5-FU from original FFX. GN consists of gemcitabine 1000mg/m2 plus nab-paclitaxel 125mg/m2 day1,8,15 every 4 weeks. We compared characteristics, efficacy and adverse events between mFFX and GN. Results: Seventy patients were treated with mFFX and 65 patients with GN as first line therapy. Demographic and baseline characteristics (mFFX/GN) were similar as follows: ECOG performance status (0-1): 100% / 99%, Gender (male): 66% / 69%, liver metastasis: 56%/49%, peritoneal metastasis: 34% / 31%, prior biliary drainage: 21%/17%, median observation period: 330 / 265 days, respectively. The population of elderly patients ( > 75y) was smaller in mFFX than GN (4.3% vs. 12%, p = 0.05). Objective response rate (27% vs. 39%, p = 0.02) and disease control rate (79% vs. 92%, p = 0.02) were significantly lower in mFFX than in GN. Median OS was 11.5 months (95% CI: 9.7-16.8) in mFFX and 14.0 months (95% CI: 12.2 - not reached) in GN. Median PFS was 5.7 months (95% CI: 3.4-7.1) in mFFX and 6.5 months (95% CI: 6.1-7.9) in GN. One-year survival rate was significantly higher in GN than in mFFX (44% vs. 67%, p = 0.0006). Incidences of grade 3 or 4 neutropenia (47% vs. 45%), diarrhea (1.4% vs. 2.0%), and peripheral neuropathy (4.2% vs. 4.6%) were similar in each group. On the other hand, incidences of febrile neutropenia (8.5% vs. 2.0%, p = 0.06) and G-CSF use rate (21% vs. 0%, p < 0.0001), anorexia (13% vs. 3%, p = 0.03) were significantly higher in mFFX than those of GN. Conclusions: Patients treated with GN showed more favorable efficacy and survival. Incidences of most adverse events did not differ between mFFX and GN,whereas febrile neutropenia occurred more frequently in mFFX.

scholarly journals Second-line chemotherapy for the treatment of metastatic pancreatic cancer after first-line gemcitabine-based chemotherapy: a network meta-analysis

Oncotarget ◽  
2018 ◽  
Vol 9 (51) ◽  
pp. 29801-29809 ◽  
Author(s):  
Chiara Citterio ◽  
Michela Baccini ◽  
Elena Orlandi ◽  
Camilla Di Nunzio ◽  
Luigi Cavanna
Keyword(s):  
Pancreatic Cancer ◽  
Meta Analysis ◽  
Metastatic Pancreatic Cancer ◽  
Second Line ◽  
First Line ◽  
Second Line Chemotherapy ◽  
Line Chemotherapy

Gemcitabine Plus Capecitabine Compared With Gemcitabine Alone in Advanced Pancreatic Cancer: A Randomized, Multicenter, Phase III Trial of the Swiss Group for Clinical Cancer Research and the Central European Cooperative Oncology Group

2007 ◽  
Vol 25 (16) ◽  
pp. 2212-2217 ◽  
Author(s):  
Richard Herrmann ◽  
György Bodoky ◽  
Thomas Ruhstaller ◽  
Bengt Glimelius ◽  
Emilio Bajetta ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Performance Status ◽  
Single Agent ◽  
Advanced Pancreatic Cancer ◽  
Phase Iii ◽  
Metastatic Pancreatic Cancer ◽  
Karnofsky Performance Score ◽  
Phase Iii Trial ◽  
Good Performance Status ◽  
Grade 3

PurposeThis phase III trial compared the efficacy and safety of gemcitabine (Gem) plus capecitabine (GemCap) versus single-agent Gem in advanced/metastatic pancreatic cancer.Patients and MethodsPatients were randomly assigned to receive GemCap (oral capecitabine 650 mg/m2twice daily on days 1 to 14 plus Gem 1,000 mg/m2by 30-minute infusion on days 1 and 8 every 3 weeks) or Gem (1,000 mg/m2by 30-minute infusion weekly for 7 weeks, followed by a 1-week break, and then weekly for 3 weeks every 4 weeks). Patients were stratified according to center, Karnofsky performance score (KPS), presence of pain, and disease extent.ResultsA total of 319 patients were enrolled between June 2001 and June 2004. Median overall survival (OS) time, the primary end point, was 8.4 and 7.2 months in the GemCap and Gem arms, respectively (P = .234). Post hoc analysis in patients with good KPS (score of 90 to 100) showed a significant prolongation of median OS time in the GemCap arm compared with the Gem arm (10.1 v 7.4 months, respectively; P = .014). The overall frequency of grade 3 or 4 adverse events was similar in each arm. Neutropenia was the most frequent grade 3 or 4 adverse event in both arms.ConclusionGemCap failed to improve OS at a statistically significant level compared with standard Gem treatment. The safety of GemCap and Gem was similar. In the subgroup of patients with good performance status, median OS was improved significantly. GemCap is a practical regimen that may be considered as an alternative to single-agent Gem for the treatment of advanced/metastatic pancreatic cancer patients with a good performance status.

Analysis of chemotherapy efficacy according to histology in malignant pleural mesothelioma (MPM) patients (p).

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e20563-e20563
Author(s):  
Susana Cedres Perez ◽  
Juan David Assaf Pastrana ◽  
Patricia Iranzo ◽  
Ana Callejo ◽  
Nuria Pardo ◽  
...  
Keyword(s):  
Prognostic Factor ◽  
Survival Data ◽  
Cox Regression ◽  
Asbestos Exposure ◽  
Performance Status ◽  
University Hospital ◽  
First Line ◽  
Neutrophil Lymphocyte Ratio ◽  
The Impact ◽  
Line Chemotherapy

e20563 Background: MPM is a highly aggressive pleural tumor associated with asbestos exposure and with limited survival despite systemic therapy. Histology is a prognostic factor and recently CheckMate 743 trial demonstrated survival benefit of immunotherapy in first line with some differences in the efficacy of chemotherapy according to histology. However, randomized trials who led to the approval of antifolate in mesothelioma did not include analysis of outcomes by histology. The objective of this study is to characterize the impact of chemotherapy according to histology in p with MPM at our institution. Methods: We review 189 MPM p diagnosed at Vall d´Hebron University Hospital between November 2002 and April 2020. Associations between clinical variables and outcome were assessed with Cox regression models and survival data were calculated by the Kaplan-Meier method. Results: Patient’s characteristics: median age 68 years (y) (45-88 y), males: 70%, performance status (PS)1: 69%, asbestos exposure: 75%, epithelioid subtype: 76%. First line chemotherapy was offered to 85% of p (66% cisplatin-pemetrexed and 27% carboplatin-pemetrexed). Median overall survival (OS) in overall population was 21.3 m (95%CI17.2-24.3). Epithelioid histology, PS 0, neutrophil-lymphocyte ratio <5 and treatment with cisplatin vs carboplatin were associated with significant improvements in OS (p<0.001). When we analyzed the survival of patients who received first line chemotherapy according to histology, we found that patients with epithelioid tumors had better PFS and OS. Median PFS for p with epithelioid tumors treated with chemotherapy in first line was 4.8 m versus 3.6 months non-epithelioid (HR1.5 CI95% 1.1-2.3; p=0.03). OS of epithelioid p treated with first line chemotherapy was 26.7 m versus 15.0 m non-epithelioid patients (HR2.25 CI95% 1.4-3.4; p<0.001). We analyzed if the differences in survival according to histology were due to type of systemic treatment received (Table). Conclusions: In our series, p with non-epithelioid tumors presented worse prognosis. We confirmed histology is a prognostic factor with better OS for p with epithelioid tumors. Moreover, we demonstrated better efficacy of chemotherapy in epithelioid tumors, although histology is not a predictive factor for the platinum agent sensitivity (p of interaction PFS=0.09, p of interaction OS= 0.65).[Table: see text]

Irinotecan in the Treatment of Colorectal Cancer: Clinical Overview

2001 ◽  
Vol 19 (5) ◽  
pp. 1501-1518 ◽  
Author(s):  
Udo Vanhoefer ◽  
Andreas Harstrick ◽  
Wolf Achterrath ◽  
Shousong Cao ◽  
Siegfried Seeber ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Topoisomerase I ◽  
Clinical Status ◽  
Phase Iii ◽  
Line Treatment ◽  
Second Line ◽  
First Line ◽  
Phase Iii Trials ◽  
Line Chemotherapy

PURPOSE AND METHODS: For more than three decades, the therapeutic options for patients with advanced colorectal cancer have almost exclusively been based on fluoropyrimidines. With the recognition that topoisomerase-I (TOP-I) is an important therapeutic target in cancer therapy, irinotecan, a semisynthetic TOP-I–interactive camptothecin derivative, has been clinically established in the treatment of colorectal cancer. RESULTS: Irinotecan was investigated as second-line chemotherapy after prior treatment with fluorouracil (FU)-based regimens in two large randomized phase III trials comparing irinotecan with either best supportive care or an infusional FU/leucovorin (LV) regimen. The outcomes of these trials established irinotecan as the standard therapy in the second-line treatment of colorectal cancer. The therapeutic value of irinotecan in the first-line treatment of metastatic colorectal cancer was investigated in two large randomized phase III trials comparing the combination of irinotecan and FU/LV with FU/LV alone. Both trials demonstrated significant superior efficacy for the combination of irinotecan and FU/LV in terms of response rate, median time to disease progression, and median survival time. Consequently, the combination of irinotecan and FU/LV has been approved as first-line chemotherapy for patients with metastatic colorectal cancer and constitutes the reference therapy against which other treatment options must be tested in the future. CONCLUSION: In this review, the clinical rationale and update of the present clinical status of irinotecan in the treatment of colorectal cancer and future prospects of irinotecan-based combinations are discussed.

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