A phase II study of S-1 in gemcitabine-refractory metastatic pancreatic cancer

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 4115-4115 ◽  
Author(s):  
C. Morizane ◽  
T. Okusaka ◽  
J. Furuse ◽  
H. Ishii ◽  
H. Ueno ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Disease Progression ◽  
Phase Ii ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
Objective Response ◽  
Advanced Pancreatic Cancer ◽  
Metastatic Pancreatic Cancer ◽  
Primary Study ◽  
Standard Regimen

4115 Background: Gemcitabine (Gem) monotherapy or Gem-containing chemotherapy is the standard first line therapy for advanced pancreatic cancer. After disease progression, there is no standard regimen available. In a previous phase II trial (J. Furuse et al, Proc ASCO 2005: # 4104), S-1 has been reported to show considerable efficacy, achieving a response rate of 37.5% in chemo-naïve patients with pancreatic cancer. This study evaluated the efficacy and toxicity of S-1 in patients with Gem-refractory metastatic pancreatic cancer. Methods: Eligibility criteria were pathologically-proven pancreatic cancer with confirmation of progressive disease while receiving Gem-based chemotherapy, Karnofsky performance status 80 to 100%, age 20 to 74 years, with measurable metastatic lesions, adequate hematological, renal and liver functions, and written informed consent. S-1 was administered orally at 40 mg/m2 twice daily for 28 days with a rest period of 14 days as one course. Administration was repeated until the appearance of disease progression or unacceptable toxicity. The primary study end point was objective response, secondary end points included toxicity, progression-free survival (PFS) and overall survival, as well as clinical benefit response in symptomatic patients. Results: Forty patients (pts) from two institutions were enrolled between September 2004 and November 2005. Thirty-three pts are currently evaluable for response in this ongoing trial. There have been 5 confirmed partial responses (12.5%), and 14 pts (35%) with stable disease. Median survival has not been reached. Median PFS was 2.1 months. Toxicity data were available for 28 patients. Grade 3 and 4 toxicities were anemia (1 pts), appetite loss (2 pts), and fatigue (2 pts). Conclusions: Preliminary results demonstrated the safety and activity of S-1 in Gem-refractory metastatic pancreatic cancer. Efficacy and toxicity analysis are ongoing. Final results will be presented at the meeting. No significant financial relationships to disclose.

A phase II study of capecitabine in combination with erlotinib as first-line therapy in patients with metastatic pancreatic cancer (stage IV).

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 277-277
Author(s):  
S. Candamio Folgar ◽  
C. Méndez Méndez ◽  
M. Jorge Fernández ◽  
C. Romero Reinoso ◽  
G. Quintero-Aldana ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Disease Progression ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Objective Response ◽  
Metastatic Pancreatic Cancer ◽  
First Line ◽  
First Line Therapy ◽  
Line Therapy

277 Background: Patients with metastatic pancreatic cancer (mPC) have poor prognosis. Given the activity of both capecitabine and erlotinib in pancreatic cancer, we hypothesized that combination use of two drugs in first-line therapy would improve clinical outcomes in these patients. Methods: A prospective, single arm, open-label, phase II study. Patients received capecitabine 1,000mg/m2 twice daily on days 1-14 in 3-week cycles combined with erlotinib 150 mg po daily for 18 weeks, until disease progression, unacceptable toxicity or withdrawal, with a follow-up visit performed at 30-days post-treatment. The primary endpoint was objective response rate measured with RECIST criteria. Results: A total of 32 patients were evaluated. Baseline characteristics: median age was 64 years (56-70), male: 50%, Karnofsky PS ≥ 80%: 94%, tumor histology: 93.5% adenocarcinoma, 49% moderately differentiated. 11 (34%) patients had surgery, 2 (6%) had prior radiotherapy and 3 (9%) prior chemotherapy. Median treatment duration was 61 days (6-156). 3 (9%) patients required dose reduction of capecitabine and 8 (25%) of erlotinib. Of the 32 patients, 6 completed the treatment period, 22 discontinued the study prematurely due to disease progression and 4 due to AEs. Disease control rate (confirmed complete response [CR], partial response [PR] and stable disease [SD] according to RECIST criteria) was 28.2%. 2 (6.3%) patients achieved PR and 7 (21.9%) had SD. After a mean follow-up of 6.3 months, the median progression-free (PFS) and overall survival (OS) was 2.10 and 4.3 months, respectively, with a 6-months survival rate of 43.8%. Safety analysis revealed that the main grade 1/2 toxicities were rash (34%), asthenia (31%), diarrhea (31%), stomatitis (22%) and emesis (22%). Three cases of grade 3 hand-foot syndrome and 1 case of infection due to biliary stent were detected. No toxicity grade 4 occurred. Conclusions: Capecitabine administered in combination with erlotinib is an active regimen in patients with metastatic pancreatic cancer with a favourable safety profile. These results suggest that this regimen could represent a first-line treatment option for these patients. No significant financial relationships to disclose.

A phase Ib study of gemcitabine plus PEGPH20 (pegylated recombinant human hyaluronidase) in patients with stage IV previously untreated pancreatic cancer.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 4010-4010 ◽  
Author(s):  
Sunil R. Hingorani ◽  
William Proctor Harris ◽  
J. Thaddeus Beck ◽  
Boris A. Berdov ◽  
Stephanie Ann Wagner ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Dose Reduction ◽  
Dose Escalation ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
Objective Response ◽  
Advanced Pancreatic Cancer ◽  
Stage Iv ◽  
Genetically Engineered ◽  
Dose Escalation Study

4010 Background: PEGPH20 is a PEGylated version of human recombinant hyaluronidase. In preclinical studies, PEGPH20 depleted pancreatic cancers of their high hyaluronan (HA) content. In a genetically-engineered murine model of PDA, PEGPH20 + gemcitabine (Gem) significantly prolonged survival compared to Gem alone. In Ph1 PEGPH20 monotherapy studies, the MTD was 3.0 μg/kg. The most common AEs were musculoskeletal events (MSEs). Methods: This was a dose-escalation study to find the recommended Phase 2 dose (RP2D) of PEGPH20 in combination with Gem in patients (pts) with Stage IV previously untreated pancreatic cancer. Pts received PEGPH20 at 1, 1.6, or 3 μg/kg IV twice a week for Wks 1-4, weekly for Wks 5-7, then 1 wk rest. Dose escalation was based on safety. Gem was given at 1000 mg/m2 IV once a week for Wks 1-7, then 1 wk rest. Thereafter, PEGPH20 + Gem were given once a week for 3 wks in 4-wk cycles. Dexamethasone was given pre and post PEGPH20 doses. Results: Of the 28 pts enrolled, the majority had a Karnofsky performance status of 80%, and 85%/19%/26% of pts had liver/lung/visceral metastases. The median age was 58 yrs. Four pts received PEGPH20 at 1 μg/kg, 4 at 1.6 μg/kg, and 20 at 3 μg/kg. The RP2D was 3 μg/kg. Treatment duration ranged from 1-274 days; 5 pts remain on study. Treatment was generally well tolerated. Ten pts had 1 Gem dose reduction, 2 pts had 1 PEGPH20 dose reduction (3 to 1.6 µg/kg), but no pt had a DLT. The most common PEGPH20-related AEs were MSEs (25% Gr1; 18% Gr2) and fatigue (21% Gr1; 11% Gr2). Objective response was assessed by an independent central radiologist using RECIST 1.1. Of the 21 pts evaluable for efficacy, 7 had partial response (PR) for an overall response rate (ORR) of 33%, and 9 had stable disease for ≥ 2 mo. Tumor biopsies from 12 pts were evaluable for HA staining. HA was high in 9 and low in 3. Of the 9 with high HA staining, 5 had PR (56% ORR); HA data were not available for the other 2 PR pts. PK results show dose-dependent exposure consistent with data from PEGPH20 monotherapy studies. Conclusions: PEGPH20 in combination with Gem is generally well tolerated in advanced pancreatic cancer and shows promising efficacy, especially in pts with high intratumoral HA content. Clinical trial information: NCT01453153.

Randomized phase II trial comparing gemcitabine/cisplatin-based chemoradiotherapy (CRT) to 5-FU-based CRT in patients with locally advanced pancreatic cancer

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 4038-4038 ◽  
Author(s):  
R. Wilkowski ◽  
H. Rau ◽  
C. Bruns ◽  
A. Wagner ◽  
R. Sauer ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Survival Rate ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
Locally Advanced ◽  
Advanced Pancreatic Cancer ◽  
End Point ◽  
Randomized Phase Ii

4038 Background: CRT is a relevant treatment option for patients with unresectable pancreatic cancer. Up to now, 5-FU has been the drug of choice for concurrent CRT. Based on evidence that also gemcitabine may improve the antitumor activity of radiation, a randomized phase II trial was undertaken. Methods: Patients with locally advanced, non-metastatic and histologically proven pancreatic cancer were included into a three-arm trial. In arm treatment arm A, radiation (CTV I up to 50.0 Gy, conventional fractionation) was applied concurrently with protracted venous infusion of 5-FU (350 mg/m2/irradiation day). In treatment arm B, patients received radiotherapy together with gemcitabine (300 mg/m2/d 30 minute infusion) and cisplatin (30 mg/m2/d 60 minute infusion) applied on days 1, 8, 22, and 29. In treatment arm C, patients received an identical regimen of CRT as described for arm B which was followed by 4 cycles of chemotherapy with gemcitabine (1000mg/m2, 30 min iv) plus cisplatin (50mg/m2) applied at 2-week intervals. Patients were stratified for Karnofsky performance status (KPS ≥80% vs. <80%). The primary end-point of the trial was the 9-months survival rate. Results: Ninety-six patients with a median age of 63.5 years (range 40–75 years) were included into the trial from 01/02 until 06/05 (arm A: 32 patients, arm B: 33 patients, arm C: 31 patients). Two patients did not complete CRT. At the time of evaluation, 66 patients (70.2%) had died. 9-months survival rate was 60%, 58%, and 46% in treatment arms A, B, and C, respectively. Median overall survival in arm A was 9.6 mo (95% CI, 8.7–10.5 mo), in arm B 9.6 mo (95%CI, 7.4–11.8 mo), and in arm C 6.1 mo (95% CI, 1.6–10 mo). Secondary end-points such as treatment-related toxicity, response rate, secondary resectability, and time to progression are under evaluation. Conclusions: CRT with gemcitabine plus cisplatin is not superior to 5-FU-based CRT with regard to the primary end-point of 9-months survival rate. Updated results will be presented at the meeting. No significant financial relationships to disclose.

Phase two clinical trial of combination oxaliplatin, irinotecan, and cetuximab for patients with locally advanced or metastatic pancreatic cancer.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e15781-e15781 ◽  
Author(s):  
Yara Abdou ◽  
Sarah Cooke Friend ◽  
Yehuda Z. Patt ◽  
Christine Gan ◽  
Fa-Chyi Lee
Keyword(s):  
Pancreatic Cancer ◽  
Clinical Trial ◽  
Disease Control ◽  
Performance Status ◽  
Objective Response ◽  
Locally Advanced ◽  
Advanced Pancreatic Cancer ◽  
Disease Control Rate ◽  
Metastatic Pancreatic Cancer ◽  
Combination Regimen

e15781 Background: Pancreatic cancer remains a leading cause of cancer death with limited treatment options. After promising results from a retrospective chart review of the combination of irinotecan, oxaliplatin, and cetuximab (OIC), a prospective phase II trial was conducted to determine the efficacy and safety of this novel combination regimen in patients with advanced pancreatic cancer. Methods: Patients aged 18 and older, with a performance status of 0-2, and a life expectancy of minimum 12 weeks were eligible if they had confirmed locally advanced or metastatic pancreatic cancer. Patients were treated with intravenous irinotecan at 90 mg/m2, oxaliplatin at 60 mg/m2, and cetuximab at 250 mg/m2on day 1 of a 14-day cycle. Treatment was continued until disease progression or unacceptable toxicity. The primary efficacy endpoint was objective response rate (ORR) and disease control rate (DCR) per RECIST 1.1 criteria. The secondary endpoints included progression free survival (PFS), overall survival (OS), and tolerability of the regimen. Results: 60 patients were enrolled and 58 were evaluable; of these, 78% had metastatic disease and 22% had locally advanced cancer at time of enrollment. 41.4% of patients had received at least one prior line of cytotoxic chemotherapy. The ORR and DCR were 6.9% and 58.6%, respectively (complete response n = 1; partial response, n = 3; stable disease, n = 30). The median PFS was 3.6 months [95 % confidence interval (CI): 2.24-4.31], and median OS was 4.8 months [95 % CI: 3.68-6.25]. The most common grade 3 or 4 toxicities were hypokalemia (20.7%), fatigue (17.2%), abdominal pain (15.5%), hyperglycemia (13.8%) and dehydration (13.8%). Conclusions: OIC on a two-week regimen was well tolerated and demonstrated a high disease control rate, encouraging further investigation of this regimen in advanced pancreatic cancer. Clinical trial information: NCT00871169.

Camrelizumab combined with ablation and chemotherapy for pancreatic cancer with liver metastases: A single-arm, phase II, prospective clinical study.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. TPS4169-TPS4169
Author(s):  
Zhiwei Li ◽  
Qingwei Li ◽  
Zhigang Ma ◽  
Yue Ma ◽  
Dan Su ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Liver Metastases ◽  
Phase Ii ◽  
Objective Response ◽  
Advanced Pancreatic Cancer ◽  
Prospective Clinical Study ◽  
Metastatic Tumors ◽  
Standard Regimen ◽  
Free Survival ◽  
Local Ablation

TPS4169 Background: Pancreatic cancer represents one of the most aggressive tumors and the majority of patients receive a diagnosis of metastatic disease, mainly in the liver, leading to poor prognosis and survival. Currently, chemotherapy has been the treatment of choice for fit patients with pancreatic cancer liver metastases (PCLM), reaching a median survival of about 5 to 7 months. In addition, local ablation of the metastatic tumors, by increasing neoantigen exposure and transforming the immune microenvironment to reduce the progression of liver metastases, might increase the survival benefit of patients. Camrelizumab, an anti-PD-1 monoclonal antibody, has obtained preliminary results in metastatic pancreatic cancer. Therefore, this study aims to explore the effectiveness and safety of camrelizumab combined with ablation and chemotherapy in the treatment of PCLM. Methods: In this single-arm, prospective, phase II study, 34 patients with histological or cytological diagnosis of PCLM, ECOG performance score of 0-1, no prior chemotherapy or the interval of adjuvant chemotherapy ≥6 months, plan to be enrolled. The enrolled patients first received ablation surgery of liver metastases, then chemotherapy (the standard regimen for advanced pancreatic cancer, determined by the investigator) combined with camrelizumab (200 mg, iv, q3w) is administered 1 week after ablation. If the patient has multiple metastatic tumors, the ablation needs to be performed in stages. The treatment regimens will continue until the disease progression, unacceptable toxicity or withdrawal of consent. The primary endpoint is 6-month progress-free survival (6-month PFS) rate (per RECIST v1.1 by researcher). Secondary endpoints are objective response rate, disease control rate, progression-free survival, overall survival and safety. On the basis of a threshold 6-month PFS rate of 25%, targeting an expected 6-month PFS rate of 44% and assuming 18 months follow-up, 80% power and a one-sided α = 0.05, this design requires 34 evaluable patients to be accrued over 2 years. Clinical trial information: NCT04420130.

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.

The prognostic value of polymorphisms in the insulin-like growth factor receptor (IGFR) pathway in patients with locally advanced pancreatic cancer (LAPC)

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 4500-4500
Author(s):  
R. T. Shroff ◽  
M. M. Javle ◽  
X. Dong ◽  
V. S. Kumar ◽  
S. Krishnan ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Induction Chemotherapy ◽  
Prognostic Value ◽  
Cox Regression ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
Locally Advanced ◽  
Advanced Pancreatic Cancer ◽  
Rank Test ◽  
Cox Regression Analysis

4500 Background: The IGFR pathway is activated in pancreatic cancer and may result in aggressive disease course. The study of single nucleotide polymorphisms (SNPs) involved in this pathway may provide prognostic information and predict response to IGFR directed agents. We investigated IGFR pathway SNPs in patients with LAPC. Methods: We evaluated 39 SNPs from 7 candidate genes in the IGFR pathway (IGF1R, IGF2R, IGF1, IGF2, IRS1, IRS2, IGFBP3) in 105 LAPC patients. DNA extraction from whole blood was performed using the Qiagen Flexigene DNA and Promega Maxwell 16 kits. Genotyping was performed using the Sequenom method. Overall survival was measured from date of diagnosis to date of death or last follow-up. Kaplan-Meier plot, log-rank test, and Cox regression were used to compare survival of patients according to genotype corrected for previously identified prognostic factors, including induction chemotherapy, CA 19–9, albumin, LDH, hemoglobin and Karnofsky performance status (KPS). Results: Median survival time (MST) was 15 months (95% CI 13.3–16.7). Induction chemotherapy, LDH, CA 19–9 level, hemoglobin, and KPS were not significantly associated with survival. Serum albumin and three SNPs of the IGF pathway (IGF1R IVS20–3431A>G, IRS1 G971R, and IGF2 *4352A>G) were significantly associated with prognosis ( Table ). Two of the three genotypes remained as significant predictors for survival in Cox regression analysis when adjusted for clinical factors. A significant combined genotype effect was observed wherein patients with all three deleterious alleles had significantly worse survival than those with only two or one (10 vs. 16.3 vs. 21.3 months, p< 0.0001). Conclusions: These data suggest that SNPs in the IGFR pathway genes may have prognostic value for LAPC patients. This information may identify population subgroups that could benefit from IGFR-targeted agents. [Table: see text] No significant financial relationships to disclose.

Phase II study of alternate-day oral therapy with S-1 for unresectable advanced pancreatic cancer: An updated report.

2013 ◽  
Vol 31 (4_suppl) ◽  
pp. 252-252
Author(s):  
Sohei Satoi ◽  
Motoki Miyazawa ◽  
Masaji Tani ◽  
Manabu Kawai ◽  
Seiko Hirono ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Adverse Effects ◽  
Phase Ii ◽  
Primary Endpoint ◽  
Advanced Pancreatic Cancer ◽  
Progression Free Survival ◽  
Final Analysis ◽  
Current Data ◽  
Standard Regimen ◽  
Grade 3

252 Background: Based on the results of GEST, S-1 was confirmed to be non-inferior to gemcitabine. However, the recommended regimen of 4 weeks of administration interrupted by 2 weeks of drug withdrawal frequently causes adverse effect. Grade3/4 toxicities (%) in S-1 were neutropenia 8.8, anorexia 11.4, diarrhea 5.5. On the other hand, we experienced in clinical practice that the alternate-day administration of S-1 reduced adverse effects and was tolerable for unresectable advanced pancreatic cancer patients unwilling to continue the standard daily administration. We therefore conducted a multi-center cooperative prospective study to compare daily with alternate-day administration of S-1 for unresectable advanced pancreatic cancer. Methods: Patients with unresectable advanced pancreatic cancer (PS, 0 to 1; age, 20 to 80 years; no other therapy) were eligible for enrollment in this trial. S-1 was administered a dose of 40 to 60 mg twice daily, assigned according to body-surface area, on Monday, Wednesday, Friday, and Sunday (specified days). Each treatment cycle will be 42 days (6 weeks). The primary endpoint was overall survival (OS). Secondary endpoints were safety, response rate (RR), progression free survival (PFS), time to treatment failure (TTF). Results: A total of 50 patients were enrolled from Sep 2009 to Feb 2011. 48 patients were evaluable for response. Male/Female was 21/27, PS: 0/1 was 40/8. With a median follow-up time of 28.2 months, OS as primary endpoint was 8.4 months (95% CI, 5.4-10.8) with the 1 year survival rate 29.2%. PFS was 5.5 months, and TTF was 3.9 months. RR was 10.4% (95% CI: 3.5-19.1), and Disease Control rate was 79.2%. Grade 3/4 hematological and non-hematological toxicities were minor. All of those adverse reactions were tolerable and reversible. Conclusions: We will report the data from the final analysis at this meeting. The current data show mitigation of adverse effects with alternate-day administration of S-1, and it appears to be a more sustainable option for unresectable advanced pancreatic cancer. A randomized phase II trial comparing this regimen of S-1 with standard regimen of S-1 is ongoing. Clinical trial information: 000003453.

Investigation of the tolerability of FOLFIRINOX in patients with unresectable advanced pancreatic cancer: Single-institution experience in Japan.

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 487-487 ◽  
Author(s):  
Kouichirou Miyashita ◽  
Takashi Sekikawa ◽  
Ken Shimada ◽  
Taikan Yamamoto ◽  
Yasuhiro Kaga ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Clinical Practice ◽  
Clinical Stage ◽  
Performance Status ◽  
Objective Response ◽  
Advanced Pancreatic Cancer ◽  
Dose Intensity ◽  
Eligibility Criteria ◽  
Grade 3 ◽  
Practice Methods

487 Background: FOLFIRINOX therapy has contributed to the overall survival extension of unresectable advanced pancreatic cancer. This regimen is however associated with significant toxicity. And doing the treatment, while careful to toxicity at our institution. We investigated the tolerability of FOLFIRINOX for the treatment of unresectable advanced pancreatic cancer in clinical practice. Methods: We conducted a retrospective analysis of patients with unresectable advanced pancreatic cancer who received FOLFIRINOX between November 2012 and August 2014. FOLFIRINOX is as follows: irinotecan at 150 mg/m2; oxaliplatin at 85 mg/m2; 5-fluorouracil (5FU) at 400mg/m2 bolus, 2,400mg/m2 continuous infusion. Patients' characteristics, objective response, survival and toxicities were collected. Response were evaluated with RECIST version 1.1 and toxicities with NCI-CTCAE version 4.0. Results: 13 patients were includes (8 males and 5 females). Treatment eligibility criteria in our institution were Performance Status 0 or 1, and UGT1A1 polymorphisms were excluded. Median age was 58.6 years (41-74). Clinical stage IVa/IVb was 3/10. The mean number therapy was 7.7 (3-15) cycles. The toxicity of all grade was 100% and grade 3 was 80%. The non-hematological toxicities included nausea in 8 patients (61.5%) and anorexia in 9 (69.2%). The hematological toxicities included neutropenia in 12 patients (92.3%), of which 11 (84.6%) presented a grade 3/4 neutropenia. In patients who developed grade 3 neutropenia, the treatment of FOLFIRINOX could be continued once every three weeks (triweekly) without reducing the dose. Response rate was 38.5% (CR: 0, PR: 5, SD: 6, PD: 2) and disease control rate was 84.6%. Time to treatment failure was 175 days. Relative dose intensity was 95.0% for oxaliplatin, 88.9% for irinotecan, 81.9% for 5FU (bolus), and 95.6% for 5FU (continuous). Conclusions: In clinical practice, it is expected that FOLFIRINOX is an effective, well-tolerated regimen by reducing the dose or determining the appropriate dosing interval.

FOLFIRINOX for patients with borderline and never-resectable locally advanced pancreatic cancer, with the addition of chemoradiotherapy for potentially resectable patients: A phase II study.

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 408-408
Author(s):  
Jon Kroll Bjerregaard ◽  
Morten Ladekarl ◽  
Anna-Lene Fromm ◽  
Per Pfeiffer
Keyword(s):  
Pancreatic Cancer ◽  
Median Survival ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Performance Status ◽  
Locally Advanced ◽  
Advanced Pancreatic Cancer ◽  
Observation Time ◽  
Stage Ii ◽  
Locally Advanced Pancreatic Cancer

408 Background: Locally advanced pancreatic cancer (LAPC) is often a mix of borderline and never-resectable tumors. Multimodality treatment might downstage these tumors to allow a potential radical resection, especially the borderline group. In this ongoing phase II study we examined the feasibility of FOLFIRINOX with or without CRT followed by surgery for both borderline and never-resectable tumors (NCT-01397019). Methods: Patients in performance status 0-1, with initially non-resectable stage II/III pancreatic cancer were offered FOLFIRINOX (oxaliplatin 85 mg/m2, irinotecan 180 mg/m2, leucovorin 400 mg/m2, 5FU 400 mg/m2+ 2400 mg/m2) every 14 days. Every 4th series the patients were evaluated and offered CRT (50.4 Gy/27F & capecitabine) if deemed potentially resectable. Resections were performed if deemed possible by the MDT. Results: Between August 2012 and present, 58 patients have been recruited with a median observation time of 14.5 months. Median age was 65(range 38-75) years, with 47%/53% stage II/III distribution. Median CA19-9 was 299(range 2-13,432). Two-hundred-seventy-four courses of FOLFIRINOX have been given, with a median of 6.5 per patient, with a median of 2 without dose modifications. Presently twenty-one patients have been treated with CRT. Twelve patients have been resected, of which 7 received prior CRT. Median survival for all patients was 15.6 months (11-NR) with a 1-year survival of 70% (49-84). For patients not resected the median survival was 12.8 months (9-16) for resected the median survival has not yet been reached. The FOLFIRINOX was associated with adverse events similar to what is expected in metastatic patients. Conclusions: FOLFIRINOX with or without CRT in patients with LAPC shows promising efficacy in patients with both borderline and never-resectable tumors. Unmodified FOLFIRINOX had acceptable toxicity, however dose reductions are often needed. CRT following initial FOLFIRINOX was feasible and without unexpected toxicity. Clinical trial information: NCT-01397019.

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