Second-line treatment of modified FOLFIRINOX or nab-paclitaxel plus gemcitabine for metastatic pancreatic adenocarcinoma.

2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 458-458 ◽  
Author(s):  
Masato Ozaka ◽  
Takashi Sasaki ◽  
Ikuhiro Yamada ◽  
Ryo Kanata ◽  
Dai Akiyama ◽  
...  
Keyword(s):  
Disease Control ◽  
Pancreatic Adenocarcinoma ◽  
Progression Free Survival ◽  
Line Treatment ◽  
Second Line ◽  
First Line ◽  
Metastatic Pancreatic Adenocarcinoma ◽  
Significant Difference ◽  
Similar Disease ◽  
First Line Treatment

458 Background: Both FOLFIRINOX (FFX) and Nab-paclitaxel plus Gemcitabine(GnP) standard treatment in first-line treatment of metastatic pancreatic adenocarcinoma (MPA). It could be of interest to use them consecutively, knowing that there is currently no standard for second-line treatments for MPA. The aim of this study was to compare second-line modified FFX (mFFX) after GnP failure with second-line GnP after mFFX failure. Methods: From January 2015 to Jul 2017, medical records were retrospectively reviewed for consecutive patients receiving mFFX or GnP for a histologically proven MPA after failure of GnP or mFFX respectively. Patients were treated with mFFX (intravenous oxaliplatin 85 mg/m2, irinotecan 150 mg/m2, 5-FU infusion 2,400 mg/m2 over 46 h, no bolus 5-FU) or GnP (Gemcitabine 1000 mg/m2/, nab-paclitaxel 125mg/m2 d1,8 15) until disease progression, patient refusal or unacceptable toxicity. Results: Second-line mFFX was administered to 50 patients and GnP was 25 patients. At baseline of second-line treatment, there was no difference in patient’s characteristics between mFFX group and GnP group. No significant difference in the response rate (mFFX, 16.6% vs. GnP, 10.5%, P = 0.63) or the disease control rate (mFFX, 50% vs. GnP, 64%, P = 0.82) was seen between the two groups. Median Progression free survival of GnP/mFFx were 4.3 months/4.6 months (p=0.89) and median survival (OS) from the 2nd line treatment of GnP/mFFx were 10.4 months/10.8 months (p=0.65) and OS from the first-line treatment of GnP/mFFx were 20.6 months/16.5 months (p=0.34). No toxic death occurred in both groups. There was no difference in the incident of adverse event between mFFX group and GnP group. Conclusions: Second-line mFFX and GnP achieved similar disease control and survival in unresectable pancreatic cancer. The use of the FFX and GnP in sequence is an attractive option to maximize disease control and survival. We need the clinical trial to compare with mFFX and GnP in sequence to guide the selection of initial chemotherapy.

Second-line systemic treatment for advanced cholangiocarcinoma.

2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 371-371 ◽  
Author(s):  
Jane Elizabeth Rogers ◽  
Lindsey Law ◽  
D. Van Nguyen ◽  
Wei Qiao ◽  
Milind M. Javle ◽  
...  
Keyword(s):  
Disease Control ◽  
Systemic Treatment ◽  
Disease Control Rate ◽  
Cancer Center ◽  
Line Treatment ◽  
Second Line ◽  
First Line ◽  
Line Therapy ◽  
Significant Difference ◽  
First Line Treatment

371 Background: Five-year survival for advanced cholangiocarcinoma (aCC) is reported at 5-10%. For advanced, unresectable patients, gemcitabine plus platinum (GEM-P) combination chemotherapy is common practice as first-line treatment with progression free survival (PFS) of 8 months and overall survival (OS) of 11.7 months. Data regarding chemotherapy treatment after first-line progression is limited. Methods: We performed a retrospective chart review of patients with aCC from 1/1/2009 to 12/31/2012 who received second-line chemotherapy at M.D. Anderson Cancer Center (MDACC). Median PFS was the primary endpoint. Secondary objectives included disease control rate (complete response + partial response + stable disease) and OS. Inclusion criteria: aCC diagnosis, progression on first-line therapy, and reimaging studies at MDACC. Exclusion criteria: patients who received localized treatment for aCC prior to second-line therapy or consolidative chemoradiation, mixed histology tumors, and those with a history of another malignancy. Results: 56 patients were identified, with the majority having intrahepatic aCC (95%). 80% of patients received gemcitabine based first-line treatment (GEM-P +/- erlotinib, GEM monotherapy). Second-line systemic treatment included GEM-P (19.6%), GEM + fluoropyrmidine (GEM-FU) (28.6%), fluoropyrmidine combination (FU-combo) (37.5%), and other consisting of chemotherapy or biotherapy monotherapy or combination (14.3%). Total median PFS was 2.7 months (95% CI = 2.3 to 3.8). Disease control rate was 50% with a median OS of 13.8 months (95% CI = 12 to19.3). No significant difference in PFS or OS was identified between the four second line treatment groups. A higher CA 19-9 at the start of second line treatment correlated with a worse survival (p= <0.01). Conclusions: This retrospective study revealed a 50% disease control rate, median PFS of 2.7 months, and a potential for improvement in OS in patients who received second line systemic treatment. Agents that may be considered include GEM + FU, FU-combination therapy, or GEM-P if not given first line.

Impact of first-line cisplatin versus non-cisplatin based chemotherapy on progression-free survival in patients with advanced urothelial carcinoma previously treated with perioperative cisplatin based chemotherapy.

2015 ◽  
Vol 33 (7_suppl) ◽  
pp. 335-335
Author(s):  
Jennifer A Locke ◽  
Gregory Russell Pond ◽  
Guru Sonpavde ◽  
Andrea Necchi ◽  
Patrizia Giannatempo ◽  
...  
Keyword(s):  
Urothelial Carcinoma ◽  
Progression Free Survival ◽  
Cox Proportional Hazards ◽  
Line Treatment ◽  
Second Line ◽  
First Line ◽  
Free Survival ◽  
Ecog Ps ◽  
Line Chemotherapy ◽  
First Line Treatment

335 Background: Perioperative cisplatin based chemotherapy (PCBC) is a standard of care in the management of muscle invasive urothelial carcinoma (UC). Cisplatin based (C) therapy also represents the historical first line treatment of metastatic disease. There is however no data to guide the optimal choice of first line chemotherapy regimen – C re-treatment vs other second-line or non cisplatin regimens (NC) –in UC patients who relapse after receiving PCBC. This multicenter retrospective study compares C vs NC first line treatment on progression-free survival (PFS) for patients (pts) with advanced UC after PCBC and cystectomy. Methods: Data were collected for patients who received various first-line chemotherapies for advanced UC following previous PCBC therapy. Cox proportional hazards models were used to investigate the prognostic ability of type of peri-operative / first-line chemotherapy, visceral metastasis, ECOG status, time from prior chemotherapy (TFPC), anemia, leukocytosis and albumin on PFS. Results: Data were available for 145 pts from 12 centers. The mean age was 62 years, 113 (77.9%) were men and ECOG-PS was 0 or >0 in 74 (51.0%) and 61 (42.0%) patients. Ninety-one (62.8%) pts received C first line, the median number of cycles was 4 (range 1-17) and the median TFPC was 6.2 months (range 1-154). Median overall survival was 86 weeks (95% CI 70-106) and median PFS was 24 (95% CI 18-27) weeks. Time from perioperative chemotherapy (TFPC) (>52 weeks vs ≤52 weeks; HR 0.63 p=0.027) and ECOG-PS at first line (1+ vs 0; HR 1.73 p=0.010), were prognostic of PFS. No significant effect was noted for C vs NC first line (p=0.70); however, among patients with TFPC >52 weeks, patients with NC had worse PFS (median 4.6 months, 95% CI 1.8-12.2) than those who received C (median 8.1, 95% CI 3.2-16.3). Conclusions: There is no evidence to suggest overall superiority of C vs NC based first line chemotherapy or a second-line regimen in patients with advanced UC who received prior PCBC. However, those with TFPC >52 weeks should probably receive C first line chemotherapy given better PFS with C.

A phase I dose escalation study of eryaspase in combination with modified FOLFIRINOX in locally advanced and metastatic pancreatic ductal adenocarcinoma.

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. TPS453-TPS453
Author(s):  
Marcus Smith Noel ◽  
Philip Agop Philip ◽  
Mohamedtaki Abdulaziz Tejani ◽  
John Marshall ◽  
Aiwu Ruth He ◽  
...  
Keyword(s):  
Overall Survival ◽  
Phase I ◽  
Pancreatic Adenocarcinoma ◽  
Locally Advanced ◽  
Progression Free Survival ◽  
Phase Iii ◽  
Line Treatment ◽  
First Line ◽  
Free Survival ◽  
First Line Treatment

TPS453 Background: FOLFIRINOX remains the standard of care for the first line treatment of patients with locally advanced and metastatic pancreatic adenocarcinoma, however the prognosis remains poor, thus novel treatment options are indicated. Eryaspase, asparaginase (ASNase) encapsulated in red blood cells (RBCs) is an investigational product under development. Following infusion, asparagine and glutamine are actively transported into RBCs where they are hydrolyzed by the encapsulated ASNase. A randomized phase IIb study in patients with advanced pancreatic cancer whose disease progressed following first-line treatment (NCT02195180) was previously conducted. Eryaspase in combination with gemcitabine monotherapy or FOLFOX combination therapy improved overall survival (OS) and progression free survival (PFS). The safety profile of eryaspase was acceptable. A second line pivotal randomized phase III trial (Trybeca-1) is currently enrolling (NCT03665441). We design this phase I study to determine the safety of mFOLFIRINOX combined with Eryaspase in the first line of treatment. Methods: Patients with locally or metastatic biopsy proven pancreatic adenocarcinoma will be treated with the combination of mFOLFIRINOX plus Eryaspase. This will be a standard 3+3 design with 4 possible doing levels. mFOLFIRINOX dosing will include 5-Fluorouracil 2400 mg/m2 over 46 hours, Oxaliplatin 85 mg/m2, Irinotecan 150 mg/m2 plus Eryaspase 75 Units/kg at dose level 0. Eryaspase will be dose escalated up to 100 Units/kg. The study will enroll at three academic centers. Key eligibility criteria include performance status 0 or 1; locally advanced or metastatic tumor disease; adequate organ function. The primary objective is to determine the maximum tolerated dose and safety of this novel combination. Key secondary objectives include objective response rate, progression-free survival, overall survival, pharmacokinetics, pharmacodynamics, and biomarker research. A data safety monitoring committee will review data every 3 months. Clinical trial information: 04292743.

Rituximab Maintenance for Advanced Follicular Lymphoma (FL) Patients - Comparison of Outcomes after First and Second Line Treatment in a Single Center Series

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 5331-5331
Author(s):  
Diana Viegas ◽  
Joana Lobato ◽  
Susana Esteves ◽  
Rita Coutinho ◽  
Maria Gomes Silva
Keyword(s):  
Disease Control ◽  
Cox Regression ◽  
Rank Test ◽  
Chemotherapy Response ◽  
Line Treatment ◽  
Second Line ◽  
Single Center ◽  
First Line ◽  
Rituximab Maintenance ◽  
First Line Treatment

Abstract Standard approach to advanced stage FL patients in need of treatment is immunochemotherapy followed by rituximab maintenance (RM). Maintenance improves disease control after first line and overall survival in the relapse setting. The relative benefits of maintenance after first or subsequent treatment have not been directly compared. Purpose: To compare the clinical outcome of patients receiving RM after first-line treatment with those who received RM for the first time after second line. Patients and Methods: We retrospectively analyzed the outcomes (time to next treatment, TTNT, and progression free survival, PFS) of a single center series of advanced FL patients in remission after first or second treatment who received RM. Demographic and clinical characteristics before first or second induction (age, gender, FLIPI and FLIPI2) as well as induction chemotherapy, response rate, PFS and TTNT were retrieved from clinical charts. Patient characteristics at the beginning of induction were compared by Chi-squared test and time-to-event outcomes evaluated by the Kaplan Meyer method and compared by log rank test, with and without stratification for FLIPI; we calculated the adjusted hazard ratio controlled for FLIPI using Cox regression; p‹0.05 was considered significant. Results: Among 371 advanced FL patients diagnosed and treated in a single center between 2001 and 2013, we identified 83 (45% male) who responded to first or second induction and received RM between 2005 and 2015 (59 after first line - M1 group - and 24 after second line - M2 group; 375 mg/m2 every 2 or 3 months for 2 years, respectively). M2 patients were older than M1 (median age 63 versus 55 yo). Other characteristics before induction were similar between the two groups, including FLIPI (low 14% and 13%, intermediate 42% and 33%, high 42% and 42% for M1 and M2, respectively; p=0.93) and FLIPI2 risk group distribution (low 10% and 4% , intermediate 49% and 38%, high 36% and 38% for M1 and M2, respectively; p=0.62). Median time from diagnosis was 5.1 years in M2 patients; M1 patients were treated at a median of 1.9 months after diagnosis. First line treatment in the M1 group was mostly RCHOP (76%) while similar proportions of M2 pts received RCHOP (38%) and RCVP (46%) as second line. 20/24 of M2 pts (83%) had received Rituximab as part of first line treatment. CR/CRu rates after induction were comparable (48% and 42% in M1 and M2 pts respectively; p=0.17). After maintenance, with 13 pts not yet evaluable for response, ORR was 68% in M1 and 50% in M2 (p= 0.15). The frequency of CR/CRu was similar for first and second line patients (43% and 42% in M1 and M2, respectively) with 10/31 (32%) and 4/11 (36%) PR patients converting to CR after M1 and M2, respectively. At a median follow-up of 2.3 in M1 and 2.5 years in M2, relapse/progression occurred in 16 (27%) and 8 (33%) patients, respectively. A new treatment was started in 19% and 29% of patients in the M1 and M2 groups. Accordingly, TTNT after M1 (not reached) was significantly longer than after M2 (33.2 months), p=0.04. This difference was not significant in stratified analysis by FLIPI. However, when controlling for FLIPI, the hazard of subsequent therapy in M2 was twice as M1 (HR=2.1; 95% CI: 0.8-5.4). Two-year PFS was also superior in M1 (80% [95% CI 70-92%] versus 62% [95% CI 44-87%] in M2) although not statistically significant (p= 0.19). Indeed, there was a 50% increase in the risk of progression or death adjusted for FLIPI in M2 compared to M1 (HR=1.5; 95%CI: 0.6-3.8). Conclusion: In this series, although patients receiving RM both after first and second induction therapy benefited from the treatment, longer treatment-free intervals and disease control were seen in the first line setting. The benefits of repeating Rituximab maintenance have not been prospectively evaluated; in countries where economic constraints impose restrictions to its repeated use, our results suggest that advanced FL patients should preferentially receive RM after first line. Disclosures Silva: Roche Pharmaceutics: Consultancy.

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