A phase II trial of gemcitabine in combination with oxaliplatin and capecitabine in previously untreated metastatic or recurrent pancreatic cancer.

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 344-344
Author(s):  
Sun Jin Sym ◽  
Junsik Hong ◽  
Minkyu Jung ◽  
Yang Seo Koo ◽  
Yeon Ho Park ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Overall Survival ◽  
Disease Progression ◽  
Pancreatic Adenocarcinoma ◽  
Single Agent ◽  
Objective Response ◽  
Survival Rates ◽  
Advanced Pancreatic Cancer ◽  
Survival Duration ◽  
One Year

344 Background: Treatment with single agent gemcitabine provides modest benefits in patients with metastatic pancreatic cancer. This study was performed to determine the efficacy of gemcitabine in combination with oxaliplatin and capecitabine in patient with recurrent or metastatic pancreatic adenocarcinoma. Methods: This was a prospective, single-arm, single center study in patients with chemotherapy-naive metastatic or recurrent pancreatic adenocarcinoma. The primary endpoint was objective response. The study was designed as a Simons two-stage optimal design and was divided into two stages. The first stage was to recruit up to 18 patients. If at least two objective responses were obtained, then a further 25 patients would be enrolled into the study. If no more than two responses were obtained among these 18 patients, the study would be halted. The study patients received gemcitabine 800 mg/m2, plus oxaliplatin 100 mg/m2 and capecitabine 800 mg/m2/day on days 1-7 every 14 days. Treatment was to be administered until disease progression or until withdrawal from the study due to unacceptable toxicity or other reasons. Results: Eighteen patients were enrolled. Median age was 63 years (range, 39-73 years). Among these 18 patients, only one patient (5.5%) achieved an objective response. Therefore, the accrual terminated. The median time to disease progression was 2.1 months, and the median overall survival duration was 4.9 months. One-year overall survival rates were 35.3%. The most frequently reported grade 3 or 4 adverse events were asthenia (16.6%), and nausea (5.5%). There were no unexpected toxicities. Conclusions: The addition of oxaliplatin and capecitabine to gemcitabine did not improve objective response in the first-line treatment of advanced pancreatic cancer patients.

A phase II trial of gemcitabine in combination with oxaliplatin and capecitabine in previously untreated metasetatic or recurrent pancreatic cancer.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e14685-e14685
Author(s):  
Sun Jin Sym ◽  
Junsik Hong ◽  
Minkyu Jung ◽  
Yang Seo Koo ◽  
Yeon Ho Park ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Overall Survival ◽  
Disease Progression ◽  
Pancreatic Adenocarcinoma ◽  
Single Agent ◽  
Objective Response ◽  
Survival Rates ◽  
Advanced Pancreatic Cancer ◽  
Survival Duration ◽  
One Year

e14685 Background: Treatment with single agent gemcitabine provides modest benefits in patients with metastatic pancreatic cancer.This study was performed to determine the efficacy of gemcitabine in combination with oxaliplatin and capecitabine in patient with recurrent or metastatic pancreatic adenocarcinoma. Methods: This was a prospective, single-arm, single center study in patients with chemotherapy-naive metastatic or recurrent pancreatic adenocarcinoma. The primary endpoint was objective response. The study was designed as a Simons two-stage optimal design and was divided into two stages. The first stage was to recruit up to 18 patients. If at least two objective responses were obtained, then a further 25 patients would be enrolled into the study. If no more than two responses were obtained among these 18 patients, the study would be halted. The study patients received gemcitabine 800 mg/m2 on day1, plus oxaliplatin 100 mg/m2 on day 1 and capecitabine 800 mg/m2/day on days 1-7 every 14 days. Treatment was to be administered until disease progression or until withdrawal from the study due to unacceptable toxicity or other reasons. Results: Eighteen patients were enrolled. Median age was 63 years (range, 39-73 years). Among these 18 patients, only one patient (5.5%) achieved an objective response. Therefore, the accrual terminated. The median time to disease progression was 2.1 months, and the median overall survival duration was 4.9 months. One-year overall survival rates were 35.3%. The most frequently reported grade 3 or 4 adverse events were asthenia (16.6%), and nausea (5.5%). There were no unexpected toxicities. Conclusions: The addition of oxaliplatin and capecitabine to gemcitabine did not improve objective response in the first-line treatment of advanced pancreatic cancer patients.

scholarly journals Systematic review and meta-analysis of gemcitabine-based chemotherapy after FOLFIRINOX in advanced pancreatic cancer

2020 ◽  
Vol 12 ◽  
pp. 175883592090540 ◽  
Author(s):  
Victor H. F. de Jesus ◽  
Marcos P. G. Camandaroba ◽  
Vinicius F. Calsavara ◽  
Rachel P. Riechelmann
Keyword(s):  
Systematic Review ◽  
Pancreatic Cancer ◽  
Pancreatic Adenocarcinoma ◽  
Meta Analysis ◽  
Single Agent ◽  
Objective Response ◽  
Advanced Pancreatic Cancer ◽  
Eligibility Criteria ◽  
Grade 3 ◽  
Advanced Pancreatic Adenocarcinoma

Background: There are no randomized data to guide treatment decisions for patients with advanced pancreatic adenocarcinoma following first-line FOLFIRINOX. We performed a systematic review and meta-analysis of studies using gemcitabine-based chemotherapy after FOLFIRINOX to assess treatment efficacy and toxicity. Methods: We included studies published between 2011 and 2018 that evaluated the efficacy and toxicity of gemcitabine-based chemotherapy after FOLFIRINOX in patients with advanced pancreatic adenocarcinoma. We searched PubMed, Embase, Scopus, and Web of Science. Primary outcomes were objective response rate (ORR), disease control rate (DCR), any grade 3/4 toxicity rate, and progression-free survival (PFS). We used the random-effects model to generate pooled estimates for proportions. Results: Sixteen studies met the eligibility criteria. Overall, ORR was 10.8%, DCR was 41.1%, and any grade 3/4 toxicity rate was 28.6%. In subgroup analyses, gemcitabine plus nab-paclitaxel was associated with superior ORR (14.4 versus 8.4%; p = 0.038) and DCR (53.5 versus 30.5%; p < 0.001) compared with single-agent gemcitabine. Median PFS ranged from 1.9 to 6.4 months and numerically favored gemcitabine plus nab-paclitaxel. Conclusions: Our study suggests gemcitabine-based chemotherapy likely outperforms best supportive care after FOLFIRINOX in advanced pancreatic cancer. Also, gemcitabine plus nab-paclitaxel seems to be more active than single-agent gemcitabine (CRD42018100421).

Phase III Trial of Gemcitabine Plus Tipifarnib Compared With Gemcitabine Plus Placebo in Advanced Pancreatic Cancer

2004 ◽  
Vol 22 (8) ◽  
pp. 1430-1438 ◽  
Author(s):  
E. Van Cutsem ◽  
H. van de Velde ◽  
P. Karasek ◽  
H. Oettle ◽  
W.L. Vervenne ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Overall Survival ◽  
Single Agent ◽  
Survival Rates ◽  
Advanced Pancreatic Cancer ◽  
Progression Free Survival ◽  
Phase Iii ◽  
Controlled Study ◽  
Double Blind ◽  
Free Survival

Purpose To determine whether addition of the farnesyltransferase inhibitor tipifarnib (Zarnestra, R115777; Johnson and Johnson Pharmaceutical Research and Development, Beerse, Belgium) to standard gemcitabine therapy improves overall survival in advanced pancreatic cancer. Patients and Methods This randomized, double-blind, placebo-controlled study compared gemcitabine + tipifarnib versus gemcitabine + placebo in patients with advanced pancreatic adenocarcinoma previously untreated with systemic therapy. Tipifarnib was given at 200 mg bid orally continuously; gemcitabine was given at 1,000 mg/m2 intravenously weekly × 7 for 8 weeks, then weekly × 3 every 4 weeks. The primary end point was overall survival; secondary end points included 6-month and 1-year survival rates, progression-free survival, response rate, safety, and quality of life. Results Six hundred eighty-eight patients were enrolled. Baseline characteristics were well balanced between the two treatment arms. No statistically significant differences in survival parameters were observed. The median overall survival for the experimental arm was 193 v 182 days for the control arm (P = .75); 6-month and 1-year survival rates were 53% and 27% v 49% and 24% for the control arm, respectively; median progression-free survival was 112 v 109 days for the control arm. Ten drug-related deaths were reported for the experimental arm and seven for the control arm. Neutropenia and thrombocytopenia grade ≥ 3 were observed in 40% and 15% in the experimental arm versus 30% and 12% in the control arm. Incidences of nonhematologic adverse events were similar in two groups. Conclusion The combination of gemcitabine and tipifarnib has an acceptable toxicity profile but does not prolong overall survival in advanced pancreatic cancer compared with single-agent gemcitabine.

A phase II study of Halichondrin B analog eribulin mesylate (E7389) as second-line therapy for patients with advanced pancreatic cancer

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e15634-e15634
Author(s):  
M. J. Moore ◽  
P. Tang ◽  
D. Renouf ◽  
P. Major ◽  
D. Hedley ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Disease Progression ◽  
Pancreatic Adenocarcinoma ◽  
Stable Disease ◽  
Survival Data ◽  
Objective Response ◽  
Locally Advanced ◽  
Advanced Pancreatic Cancer ◽  
Eribulin Mesylate ◽  
Halichondrin B

e15634 Background: Eribulin mesylate is a halichondrin B analog that inhibits microtubule dynamics by a mechanism that is distinct from other tubulin-targeted agents. Preclinical studies suggest that Eribulin may be effective in pancreatic cancer. The primary objective of this study was to determine the objective response rate (complete and partial) to Eribulin in patients with advanced, pancreatic adenocarcinoma that had progressed after gemcitabine based therapy. Methods: Eligibility criteria included histologically confirmed pancreatic adenocarcinoma; measurable locally advanced, or metastatic disease; disease progression after gemcitabine; and ECOG performance status 0–2. Patients (pts) received Eribulin mesylate 1.4 mg/m2 IV on days 1 and 8. Treatment was repeated every 3 weeks in the absence of disease progression or unacceptable toxicity. Response was assessed by CT scans every 6 weeks while on treatment. Initially 12 pts were to be accrued, if 1 or more pt(s) had an objective response the accrual would increase to a total of 37. Results: 15 pts were accrued,14 received treatment and 12 were evaluable for response. Median age 61; M:F = 8:7; ECOG 1:2 = 11:4; Median number of cycles 2 (1–15). Grade 3+ adverse events included neutropenia (29%), fatigue (14%), peripheral neuropathy (7%) and thrombosis (7%). There were no complete or partial responses, and therefore the study was closed at the first accrual cut off. The best response was stable disease (SD) in 5/12 (42%) pts. Of these 5 pts, 3 (42%) had SD for 12 cycles or greater. Survival data is pending. Conclusions: Eribulin was well tolerated and did not result in any objective responses in refractory pancreatic cancer. However, 42% of pts had stable disease and for 3 pts this was maintained for more than 9 months. Further studies of eribulin in pancreatic cancer may be warranted. No significant financial relationships to disclose.

scholarly journals Phase II Trial of Cetuximab, Gemcitabine, and Oxaliplatin Followed by Chemoradiation With Cetuximab for Locally Advanced (T4) Pancreatic Adenocarcinoma: Correlation of Smad4(Dpc4) Immunostaining With Pattern of Disease Progression

2011 ◽  
Vol 29 (22) ◽  
pp. 3037-3043 ◽  
Author(s):  
Christopher H. Crane ◽  
Gauri R. Varadhachary ◽  
John S. Yordy ◽  
Gregg A. Staerkel ◽  
Milind M. Javle ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Overall Survival ◽  
Disease Progression ◽  
Phase Ii ◽  
Radiation Treatment ◽  
Phase Ii Trial ◽  
Locally Advanced ◽  
Advanced Pancreatic Cancer ◽  
Survival Duration ◽  
Acneiform Rash

Purpose This phase II trial was designed to assess the efficacy and safety of cetuximab, gemcitabine, and oxaliplatin followed by cetuximab, capecitabine, and radiation therapy in locally advanced pancreatic cancer (LAPC). Patients and Methods Treatment-naive eligible patients (n = 69) received intravenous gemcitabine (1,000 mg/m2) and oxaliplatin (100 mg/m2) every 2 weeks for four doses, followed by radiation (50.4 Gy to the gross tumor only) with concurrent capecitabine (825 mg/m2 twice daily on radiation treatment days). Cetuximab (500 mg/m2) was started on day 1 of chemotherapy and was continued every 2 weeks during chemotherapy and chemoradiotherapy. Diagnostic cytology specimens were immunostained for Smad4(Dpc4) expression. Results Median overall survival time was 19.2 months (95% CI, 14.2 to 24.2 months), and 1-year, 2-year, and 4-year actuarial overall survival rates were 66.0%, 25.02%, and 11.3%, respectively. Acneiform rash correlated with improved survival (P = .001), but initial CA19-9, borderline resectable initial stage, and surgical resection (n = 7) did not. The 1-year and 2-year radiographic local progression rates were 22.8% and 61.0%, respectively. The worst acute toxic effects were GI toxicity (32% and 10% for grades 2 and 3, respectively); fatigue (26% and 6% for grades 2 and 3, respectively); sensory neuropathy (9% and 1% for grades 2 and 3, respectively); and acneiform rash (54% and 3% for grades 2 and 3, respectively). Smad4(Dpc4) expression correlated with a local rather than a distant dominant pattern of disease progression (P = .016). Conclusion This regimen appears effective and has acceptable toxicity. The primary end point (1-year overall survival rate > 45%) was met, with encouraging survival duration. Smad4(Dpc4) immunostaining correlated with the pattern of disease progression. Prospective validation of Smad4(Dpc4) expression in cytology specimens as a predictive biomarker is warranted and may lead to personalized treatment strategies for patients with localized pancreatic cancer.

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 lapatinib and capecitabine in first-line treatment of metastatic pancreatic cancer (ICORG 08- 39).

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 315-315 ◽  
Author(s):  
R. S. McDermott ◽  
P. Calvert ◽  
M. Parker ◽  
G. Webb ◽  
B. Moulton ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Overall Survival ◽  
Cancer Patients ◽  
Advanced Pancreatic Cancer ◽  
Metastatic Pancreatic Cancer ◽  
Survival Duration ◽  
Synergistic Activity ◽  
Line Treatment ◽  
First Line ◽  
First Line Treatment

315 Background: The combination of capecitabine plus erlotinib in gemcitabine-refractory advanced pancreatic cancer patients has proved beneficial in terms of median survival duration, objective radiological response rate and decrease in tumour marker levels from baseline. In the phase I study of capecitabine and lapatinib carried out in advanced solid tumors, the optimal tolerated regimen was determined to be lapatinib 1,250 mg plus capecitabine 2,000 mg/m2/day. At these dose levels, the combination was well tolerated with few grade 3 toxicities and no grade 4 toxicity. Our preclinical work suggested synergistic activity of capecitabine and lapatinib in pancreatic cancer. We initiated a study of this combination in the first-line therapy of metastatic pancreas cancer. Methods: This was a single-arm multicenter study in patients with chemotherapy-naive metastatic pancreatic cancer. The primary endpoint was overall survival. The study was designed as a Simons two-stage optimal design and was divided into two stages. The first stage was to recruit up to 12 patients. If at least seven of these patients survived for at least six months, then a further 20 patients would be enrolled into the study. If six or fewer of the initial 12 patients met the specified study survival criteria, the study would be halted. Treatment was to be administered until disease progression or until withdrawal from the study due to unacceptable toxicity or other reasons. Clinical and laboratory parameters were assessed to evaluate disease response and toxicity of therapy. The study patients received lapatinib 1,250 mg/day, plus capecitabine 2000 mg/m2/day on days 1-14 every 21 days. Results: Nine patients were enrolled. Seven of these patients did not achieve the interim protocol response requirement of survival for at least 6 months, to allow for the study to continue to the second cohort of patients. Median overall survival from first dose was 4 months. Median time on treatment was 2 months. There were no objective responses. There were no unexpected toxicities. Conclusions: The addition of lapatinib to capecitabine does not improve overall survival in the first-line treatment of advanced pancreatic cancer patients. [Table: see text]

Hypofractionated radiotherapy for patients with locally advanced pancreatic cancer using tomotherapy Hi-Art and CyberKnife: A study of the treatment outcome and failure patterns.

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 342-342
Author(s):  
H. Jang
Keyword(s):  
Pancreatic Cancer ◽  
Treatment Outcome ◽  
Locally Advanced ◽  
Advanced Pancreatic Cancer ◽  
Locally Advanced Pancreatic Cancer ◽  
Hypofractionated Radiotherapy ◽  
Ulcer Bleeding ◽  
Survival Duration ◽  
Response Evaluation ◽  
One Year

342 Background: To evaluate the treatment outcome and pattern of failure in the patients with locally advanced pancreatic cancer, who were treated with hypofractionated radiotherapy (RT) using TomoTherapy Hi-Art and Cyberknife. Methods: From April 2004 to May 2010, Twenty four patients with locally advanced pancreatic cancer received hypofractionated RT using TomoTherapy Hi-Art and Cyberknife at Seoul St. Mary's Hospital, the Catholic University of Korea. Eleven patients (45.8%) were treated using TomoTherapy Hi-Art and 13 patients (54.2%) using Cyberknife. The total dose delivered were 45∼55 Gy (median: 50 Gy) in 15∼22 fractions with TomoTherapy Hi-Art and 24∼40 Gy (median 30 Gy) in 3∼5 fractions with Cyberknife. The RECIST version 1.1 was used for the response evaluation. The follow-up duration was 3.0∼77.1 months (median: 34 months). Results: In the initial response evaluation, the rates of partial response, stable disease and progressive disease were 45.8%, 54.2% and 0%, respectively. Median survival duration was 11.1 months. One year and two year survival rates were 39.4% and 21.1%, respectively. Two patients (8.3%) had local failures and 11 patients (45.8%) had distant failures. Distant failures were main cause of failures. Median time to distant failures was 7.8 months and one year distant progression-free survival rate was 35.1%. The difference of the treatment outcome between TomoTherapy Hi-Art and Cyberknife was not statistically significant. Most patients experienced abdominal discomfort and pain after RT. However, no severe gastrointestinal complication such as ulcer, bleeding, perforation and fistula were noted. Conclusions: Hypofractionated RT for the patients with locally advanced pancreatic cancer showed excellent local control. However, overall survival still remains poor because of distant failures. Therefore, effective systemic chemotherapy should be considered with RT, either concurrently or sequentially. No significant financial relationships to disclose.

A multicenter, phase IV study of the effectiveness of palliative gemcitabine in patients with advanced pancreatic cancer.

2012 ◽  
Vol 30 (34_suppl) ◽  
pp. 46-46
Author(s):  
David Wallace ◽  
Jina Zhang-Salomons ◽  
Christopher M. Booth ◽  
William J. Mackillop
Keyword(s):  
Pancreatic Cancer ◽  
Overall Survival ◽  
Clinical Practice ◽  
Clinical Benefit ◽  
Single Agent ◽  
Advanced Pancreatic Cancer ◽  
Well Being ◽  
Routine Clinical Practice ◽  
Assessment System ◽  
Patient Reported

46 Background: Randomized controlled trials (RCTs) have shown that palliative gemcitabine provides clinical benefit and prolongs survival in patients with advanced pancreatic cancer. The purpose of this study was to determine if the efficacy of palliative gemcitabine demonstrated in RCTs has translated into effectiveness in routine clinical practice in Ontario. Methods: This was a retrospective cohort study of all patients with exocrine cancer of the pancreas treated with first line, single agent, palliative gemcitabine at all 13 provincial cancer centres in Ontario between 2008 and 2011. These patients were identified by linking electronic records of treatment from all cancer centres and hospitals in Ontario to the Ontario Cancer Registry. Patient-reported well-being and symptoms were captured by the Edmonton Symptom Assessment System, which has been in routine use at these centres since 2008. The effectiveness of gemcitabine was measured in terms of clinical benefit at two months and overall survival. Patients were classified as having achieved clinical benefit if they had not discontinued gemcitabine and their self-reported well-being was stable or improved at two months. Results: The study population included 423 patients. Their median age was 65 and 50% were women. Fifty-seven percent had stage IV disease, 17% had stage III disease, and 10% had recurrence after earlier treatment for stage I or II disease. Patients included in this study were older than, but otherwise similar to, patients enrolled in four relevant RCTs that used gemcitabine in the experimental or control arm. At two months, 36.9% (95% CI 29.6-44.2%) of patients in this study achieved clinical benefit, which was within the range of 24% to 56% observed in patients in these trials. Median overall survival was 5.7 months (95% CI 4.7-6.1), which was within the range of 5.4 to 6.9 months reported in the trials. Conclusions: The efficacy of gemcitabine demonstrated in RCTs has translated into effectiveness in routine clinical practice in Ontario. The approach described above could readily be used to study the effectiveness of other palliative interventions.

Resection of pancreatic cancer following induction chemotherapy.

2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 406-406
Author(s):  
Walid Labib Shaib ◽  
Layal Sayegh ◽  
Olatunji Alese ◽  
Shishir Maithel ◽  
Kenneth Cardona ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Overall Survival ◽  
Combination Chemotherapy ◽  
Systemic Disease ◽  
Single Agent ◽  
Locally Advanced ◽  
Survival Rates ◽  
Neoadjuvant Treatment ◽  
Rank Test ◽  
Borderline Resectable

406 Background: Survival of resectable pancreas cancer (RPC) treated with resection and adjuvant therapy is 22-28 months (mo). Locally advanced unresectable pancreatic cancer (LAPC) treated with combination chemotherapy have a median survival of 24 mo. The objective of this project is to evaluate the effect of neoadjuvant treatment on survival outcome of localized PC. Methods: Charts of localized PC patients treated at Emory University from 2009 to 2016 were reviewed. Information on demographics, stage and treatment was collected. Survival rates were estimated by Kaplan-Meier method and compared with log-rank test. A Cox proportional hazard model was fitted to estimate the adjusted effect of treatment on overall survival(OS). Results: A total of 415 patients were included; 144 RPC, 158 borderline resectable (BRPC) and 108 LAPC. Stage was determined at the multidisciplinary conference. The median age was 67.7 years (30-92); 49% male, and 63% Caucasians. The median OS for RPC, BRPC, and LAPC was 16.9, 14.6 and 10.9 mo, respectively. Stage, type of chemotherapy and age were significant predictors of OS after adjusting for gender, race, age, surgery, stage, chemotherapy, margins and radiation. Of the 144 RPC, 137 underwent surgery and 3 received neoadjuvant treatment; 73 RPC were followed in outside facility with missing follow up data. Of the 71 RPC treated at Emory; 91% received adjuvant gemcitabine. Of the 158 BRPC, 84 underwent surgery; 44 received FOLFIRINOX neoadjuvant therapy, 23 received gemcitabine/nab-paclitaxel, and 16 received gemcitabine single agent. BRPC patients who underwent resection had a median OS of 18.5 mo (95%CI: 14.2, 26.4), significantly longer than RPC (P = 0.044). Combination chemotherapy was significantly associated with improved OS at 36 mo (38.9%) when compared to single agent gemcitabine (6.3% at 36 mo) (p = 0.009). BRPC patients who received FOLFORINOX and surgery had a median OS of 31.5 mo. Conclusions: Overall survival of BRPC patients who undergo resection after FOLFIRINOX is significantly improved (more than doubled) compared to upfront resection for RPC. Preoperative therapy provides the best approach for systemic disease early in the course of treatment.

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