Effect of the addition of platinum to gemcitabine on outcome in patients with advanced pancreatic cancer who progress on gemcitabine: A comprehensive analysis of published trials.

2013 ◽  
Vol 31 (4_suppl) ◽  
pp. 275-275
Author(s):  
Osama E. Rahma ◽  
David J. Liewehr ◽  
Seth M. Steinberg ◽  
Austin G. Duffy ◽  
Tim F Greten
Keyword(s):  
Pancreatic Cancer ◽  
Overall Survival ◽  
Locally Advanced ◽  
Advanced Pancreatic Cancer ◽  
Standard Of Care ◽  
Second Line ◽  
Second Line Therapy ◽  
Line Therapy ◽  
General Search ◽  
Line Setting

275 Background: Pancreatic cancer is one of the deadliest cancers with an estimated 5 years survival rate of 5%. Until recently gemcitabine had been considered the first line treatment for locally advanced or metastatic disease. Although many chemotherapy regimens have been used there is no standard of care for second line therapy. The aim of this analysis was to identify superior regimen in the second line setting. Methods: We conducted a general search on PubMed for “second line therapy in advanced pancreatic cancer”. We limited our search to trials published in English from 2000 through 2012. Studies presented as abstracts in major meetings were also included. Trials that used targeted therapy other than erlotinib were excluded. We compared in an exploratory fashion the RR, PFS and OS of BSC and each of the following regimens to the rest of the treatments: 5FU+platinum, gemcitabine+platinum, taxol, erlotinib. In addition, we compared the combinations of platinum with either 5FU or gemcitabine. Finally, we explored the trend of these treatments outcomes over time. Results: Forty-four trialswere identified, of which 34 trials (T) met the inclusion criteria treating 1503 patients (N). There was a trend toward an improved overall survival with treatments (T: 33; N: 1269) compared to BSC (T: 2; N: 234) only (P= 0.013). The combination of gemcitabine and platinum (T: 5; N: 154) was the only regimen that showed a trend toward superior outcomes compared to the other regimens (T: 28; N: 1115) in terms of RR and PFS (P= 0.006 and 0.059, respectively). However, there was no difference in overall survival (P= 0.10). When compared to 5FU+platinum (T: 12; N: 450) the regimen of gemcitabine+platinum (T: 5; N: 154) showed only a trend toward significance in terms of improved RR (P= 0.030) with no difference in PFS or OS (P= 0.60 and 0.22, respectively). Overall, there was a trend toward a worse RR and PFS with no change in OS over the past 13 years. Conclusions: The combination of gemcitabine and platinum may provide a valid second line option in patients with locally advanced or metastatic pancreatic cancer who progress on gemcitabine.

Phase II Study of Docetaxel and Gefitinib as Second-Line Therapy in Gemcitabine Pretreated Patients with Advanced Pancreatic Cancer

Oncology ◽  
2009 ◽  
Vol 76 (4) ◽  
pp. 270-274 ◽  
Author(s):  
Joanna M. Brell ◽  
Khalid Matin ◽  
Terry Evans ◽  
Robert L. Volkin ◽  
Gauri J. Kiefer ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Advanced Pancreatic Cancer ◽  
Second Line ◽  
Second Line Therapy ◽  
Line Therapy ◽  
Pretreated Patients

Determinants of first-line treatment selection in advanced pancreatic ductal adenocarcinoma (PDAC).

2017 ◽  
Vol 35 (4_suppl) ◽  
pp. 468-468
Author(s):  
Hui-Li Wong ◽  
Ying Wang ◽  
Yaling Yin ◽  
Hagen F. Kennecke ◽  
Winson Y. Cheung ◽  
...  
Keyword(s):  
Overall Survival ◽  
Locally Advanced ◽  
Treatment Selection ◽  
Line Treatment ◽  
Second Line ◽  
First Line ◽  
Second Line Therapy ◽  
Line Therapy ◽  
The Impact ◽  
First Line Treatment

468 Background: Chemotherapy options currently available for the first-line treatment of advanced PDAC include FOLFIRINOX (FX), gemcitabine with nab-paclitaxel (GP) and single agent gemcitabine (Gem). GP was introduced most recently and funded for clinical use in British Columbia (BC) in September 2014. In this retrospective analysis, we explore the impact of GP availability on first-line treatment selection and overall survival (OS) in advanced PDAC. Methods: The BC Cancer Agency provincial pharmacy database was used to identify patients (pts) who started FX, GP or Gem between January and August 2014 (pre-GP) or January and August 2015 (post-GP). Pts were eligible for inclusion if they received at least one cycle of first-line therapy for locally advanced or metastatic PDAC. Clinical data were extracted from electronic medical records. OS was defined as time from diagnosis of advanced PDAC to death and compared by treatment era, adjusting for age, ECOG, comorbidities, disease extent and baseline CA19-9. Results: 286 pts fulfilled eligibility criteria: 88 (31%) with locally advanced and 198 (69%) with metastatic disease. 131 and 155 pts were treated in the pre- and post-GP eras respectively. Prior to GP approval, 44% and 49% of pts received Gem and FX; this decreased to 21% and 33% after GP funding, with 46% of pts receiving GP in the latter period. Nine (7%) pts received GP in the pre-GP era, either through self-pay or addition of nab-paclitaxel after approval. There were no significant differences in pt characteristics across both eras. 46% of pts who received GP post approval had ECOG ≥ 2. The proportion of pts receiving second-line therapy was lower in the post-GP era (22% vs. 38%). Median OS in the post-GP era was 8.1 vs. 10.1 months in the pre-GP era; adjusted HR 1.28 (95% CI 0.96–1.71). Pts with ECOG ≥ 2 who received GP had a median OS of 6.5 months. Conclusions: After GP was funded, it became the preferred first-line regimen for advanced PDAC. Its more frequent use instead of FX did not appear to compromise overall survival even though a substantial proportion of pts were ECOG ≥ 2 and few pts received second-line therapy.

Pulsed high-dose erlotinib with gemcitabine as second-line therapy for pancreatic adenocarcinoma.

2019 ◽  
Vol 37 (4_suppl) ◽  
pp. 421-421
Author(s):  
Christopher Larson ◽  
Tony R. Reid
Keyword(s):  
Pancreatic Cancer ◽  
Overall Survival ◽  
Dose Escalation ◽  
High Dose ◽  
Second Line ◽  
First Line ◽  
Second Line Therapy ◽  
First Line Therapy ◽  
Line Therapy ◽  
Recommended Phase Ii Dose

421 Background: The options for treatment of pancreatic cancer follow progression on first line therapy are limited and associated with significant toxicity. Erlotinib has been approved for treatment of pancreatic cancer in first-line therapy. We conducted a phase I dose-escalation trial of erlotinib in combination with gemcitabine for patients that had failed first-line therapy. Erlotinib was administered by a novel pulse-dose schedule where the drug was given orally for 3 days every two weeks. Purpose: Assess the safety and determine a recommended phase II dose for pulsed high dose erlotinib in combination with gemcitabine for pancreatic cancer, and obtain preliminary data on activity. Methods: Patients with pancreatic cancer that progressed on or after first-line therapy were treated in a dose escalation study with erlotinib at 750 to 2,000 mg daily for three days every two weeks in combination with weekly gemcitabine at 1,000 mg/m2 for three weeks on and one week off. Results: No dose limiting toxicities were encountered and erlotinib-induced rash was mild and transient. Median overall survival was 6.7 months and 12-month overall survival was 27%. Progression free survival but not overall survival was longer in patients who did not previously receive gemcitabine. Rash was not associated with longer survival. Conclusions: The recommended phase II dose is erlotinib 2,000 mg daily for three consecutive days every two weeks in combination with gemcitabine. Tolerability was excellent, and outcomes were better than expected for second-line therapy in pancreatic cancer. Further studies are warranted, both as therapy after first-line and as first-line therapy for patients unable to tolerate more aggressive regimens. Clinical trial information: NCT02154737.

Second-line therapy with pemetrexed after gemcitabine failure in patients with unresectable locally advanced or metastatic pancreatic cancer: A multicenter phase II trial

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 4124-4124 ◽  
Author(s):  
S. Boeck ◽  
K. Weigang-Koehler ◽  
M. Fuchs ◽  
E. Kettner ◽  
D. Quietzsch ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Survival Rate ◽  
Phase Ii ◽  
Single Agent ◽  
Locally Advanced ◽  
Metastatic Pancreatic Cancer ◽  
Second Line ◽  
First Line ◽  
Second Line Therapy ◽  
Line Therapy

4124 Background: There is no established second-line therapy for advanced pancreatic cancer after failure of standard first-line treatment with gemcitabine. In view of the urgent need of such therapy and the observation of clinically meaningful responses with pemetrexed in previously untreated pancreatic cancer, this phase II study evaluated pemetrexed as second-line therapy. Methods: This study was planned to evaluate the efficacy and safety of pemetrexed in 54 patients (pts) with unresectable locally advanced or metastatic pancreatic cancer (stage II-IV), ECOG performance status ≤2 and estimated life expectancy of ≥12 weeks (wks) after failure of first-line gemcitabine single agent or combination therapy. Pemetrexed was started at 500 mg/m2 q3w (10 min infusion), with vitamin B12 and folic acid supplementation. Dose escalation by 100 mg/m2 every other cycle and an unlimited number of cycles were allowed. Primary endpoint was the 3-month survival rate. Results: A total of 189 treatment cycles (median 2, range 1–20) was given to 52 pts (60% male, median age 63 yrs, median time since initial diagnosis 32 wks, 89% stage IV disease). Doses were escalated in 2 pts (4%) and reduced due to toxicity in 9 pts (17%); median dose per cycle was 500 mg/m2 (range 212–700 mg/m2). The 3-month survival rate was 75% (95% CI 63.2–86.8%). At a median follow-up of 20 wks, the median overall survival estimate was 20 wks, with 9 pts alive including 1 still on pemetrexed. Median TTP was 7 wks (range 1–62 wks). The overall response rate was 3.8% (0 CR, 2 PR); 12 pts (23%) had SD for ≥6 wks, 9 of them for ≥12 wks. CA 19–9 decreased at least once by ≥ 50% in 12 pts (23%). Grade 3/4 hematological toxicity rates per pt were as follows: neutropenia 17.3% (febrile neutopenia: 3.8%), leukopenia 15.4%, thrombopenia 5.8% and anemia 3.8%. Conclusion: Pemetrexed is a feasible option for second-line therapy with mild toxicity and encouraging activity in unresectable locally advanced or metastatic pancreatic cancer after gemcitabine failure. [Table: see text]

Modified FOLFIRINOX (mFOLFIRINOX) as second-line chemotherapy in pancreatic adenocarcinoma.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e15747-e15747
Author(s):  
Andrew Peter Dean ◽  
Domenic Higgs ◽  
Alex James ◽  
Tegan Van Gemert ◽  
Alena Talia James
Keyword(s):  
Pancreatic Adenocarcinoma ◽  
Performance Status ◽  
Locally Advanced ◽  
Young Patients ◽  
Dose Intensity ◽  
Second Line ◽  
Second Line Therapy ◽  
Line Therapy ◽  
Accord Study ◽  
Line Setting

e15747 Background: FOLFIRINOX is a highly effective combination chemotherapy regimen with the reputation of only being tolerable to young patients with good performance status. As the original ACCORD study was carried out at specific French university hospitals with patients performance status 0 or 1 many oncologists feel uncomfortable administering mFOLFIRINOX as a second-line therapy. We have previously reported our experience in 24 patients ages 27 - 84 where we concluded that dose modified FOLFIRINOX can be safely administered to elderly patients with appropriate initial dose reductions and subsequent escalation. There is a lack of consensus on a standard second-line regimen for metastatic pancreatic cancer. We conducted a review of dose intensity and outcome for all patients treated with 2nd or 3rd-line mFOLFIRINOX for pancreatic adenocarcinoma at St John of God Hospital, Subiaco, Western Australia in order to assess efficacy and tolerability Methods: Electronic records were used to identify 35 patients who had received 1st-line gemcitabine-based chemotherapy who then went on to receive 2nd or 3rd line mFOLFIRINOX. Case files, laboratory and radiology records were then examined to determine outcomes and toxicities. Results: 35 patients were identified with an age range of 27- 85, both locally advanced and metastatic disease, with 12 over the age of 70. All patients except 2 had gemcitabine plus abraxane in the first line setting. Dose intensity was 65% for oxaliplatin, 68% for irinotecan, 18% for bolus 5-FU and 68% fir infusional 5FU. Toxicity was acceptable with a grade 3 toxicity rate of 10%. Overall survival in this group ranged from 5-67 months (median 23 months for locally advanced / 15 months for metastatic). Notably, 20 patients received greater than 6 cycles of treatment and 8 patients received more than 12 cycles. One patient has received 70 cycles. Conclusions: Our experience demonstrates the safety, tolerability and efficacy of mFolfirinox as a second-line therapy after gemcitabine failure. The disease control rate, even with the reduction in dose intensity, suggests that modified Folfirinox should be formally tested in the 2nd line setting in a clinical trial.

Sign in / Sign up

Export Citation Format

Share Document