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. 2014 Sep;7(4 Suppl 1):S19–S20.

FOLFOX + Nab-paclitaxel (FOLFOX-A) for Advanced Pancreatic Cancer: A Brown University Oncology Research Group Study

Howard Safran 1, Kalyan Mantripragada 1, Kimberly Perez 1, Kevin Charpentier 1, Thomas Miner 1, Thomas Dipetrillo 1, Benjamin Kuritzky 1, Kenneth D Bishop 1, Emmanuel Apor 1, Kayla Rosati 1
PMCID: PMC4812841

ABSTR 1415 – Oral Presentation

Background:

The Brown University Oncology Research Group sought to improve the activity of FOLFIRINOX in pancreatic cancer by removing irinotecan and substituting Nab-paclitaxel. A phase I study of FOLFOX-A was initiated.

Methods:

Patients with newly diagnosed advanced pancreatic adenocarcinoma, bilirubin ≤ 1.5x uln, AST and ALT ≤ 3x uln and PS 0–1 were eligible. Patients received oxaliplatin 85 mg/m2, leucovorin 400 mg/m2 and 5-FU 2400 mg/m2 with 3 dose levels of nab-P (125, 150 and 175 mg/m2) every 2 weeks.

Results:

Thirty-two patients have been entered; 22 with metastatic and 10 with locally advanced pancreatic cancer. The maximum tolerated dose of Nab-paclitaxel was 150 mg/m2 every 2 weeks with FOLFOX. Grade 3 neuropathy developed in 2 of the first 9 patients after 10 cycles of therapy. The final dose level was expanded to evaluate an amendment to reduce oxaliplatin to 65 mg/m2 for any patient developing grade 2 neuropathy. While patients remain on active protocol treatment, thus far no further patients have developed grade 3 neuropathy. Treatment has been well tolerated with 2 patients developing grade 4 neutropenia and 2 patients developing grade 3 diarrhea. Twelve of the first 25 patients (48%) have had a partial response. The median survival for patients with metastatic disease is 14 months.

Conclusions:

The MTD of nab-P is 150 mg/m2 every 2 weeks with FOLFOX. The regimen of FOLFOX-A has substantial activity, is well tolerated, and represents a promising treatment for pancreatic cancer. Additional studies in the metastatic and adjuvant setting are ongoing.

Supported by the Davis and Browning families and LIFEcycle.

Clinical trial information: NCT01744353.

Gastrointest Cancer Res. 2014 Sep;7(4 Suppl 1):S19–S20.

The Impact of Adjuvant Chemotherapy (CT) Versus Adjuvant Chemo-radiotherapy (CRT) on Patients with Resected Pancreatic Cancer: A Retrospective Review from Tertiary Hospital in Saudi Arabia

Hossam Abdel Rhaman 1, Halah Al-Enizi 2, Mohamed E El Sayed 3,4, Ehab M Abdulghany 1,5, Bakr Ben Sadiq 2

ABSTR 1416 – Oral Presentation

Background:

Pancreatic cancer is the 4th leading cause of cancer death in the United States with Less than 5% of patients surviving five years after diagnosis. Surgery remains the only potentially curative treatment modality for pancreatic cancer. Even after complete resection, the overall survival remains dismal due to high recurrence rates. Adjuvant therapy may improve long-term survival. The results from randomized phase III trials with regard to the type of adjuvant therapy are conflicted. Some trials favored combined chemo-radiotherapy (CRT) while others favored single modality chemotherapy (CT) and even suggested that adding radiation therapy could be detrimental.

Purpose:

To review the pattern of adjuvant therapy use following resection of pancreatic cancer at King Faisal Specialist Hospital and Research Center – Jeddah (KFSHRC-J), between 2001–2013 and to assess the impact of different types of adjuvant therapy on Saudi population.

Methods:

A retrospective chart review of 56 pancreatic cancer patients who underwent Whipple procedure at KFSHRC-J, from 2001 to 2013. Case finding was done through Oncology Data Unit. All the statistical analysis performed using the software SPSS (version 20).

Results:

The mean age was 57.5±12.8 years. Two third of the patients were males. Forty eight patients (86%) had the tumor located in the head of the pancreas. Forty one patients (73 %) had obstructive jaundice at presentation and twenty six patients (46%) had elevated CA19.9 levels. Thirty nine cases (70%) had adenocarcinoma while 6 cases (12.2%) had adenosquamous histology. Surgical margins were reported negative in 41 patients (73%). The mean number of lymph node resected was 12 and N1 disease was reported in 30 patients (54%). 31 patients (60.8%) had stage IIB disease. Only 19 patients (34%) received adjuvant therapy following surgery; 11 patients had adjuvant single modality CT while 7 patients had adjuvant CRT (5FU based chemotherapy), and one patient received radiation therapy alone. Grade 3 and 4 hematological toxicity was observed in 4/7 patient in CRT (57%) Vs 3/11 patients (27%) in CT group. At a median follow up of 23 months (16.6–29.4 months); 26 patients (46%) had documented relapses; 11 and 15 patients in the surgery alone and in the adjuvant group respectively. Of the twenty six relapses, 10 patients had localized relapse only, 8 patients had localized and distant relapse, and 8 patients had distant relapse only. The median duration of disease free survivals for adjuvant CT and adjuvant CRT were 10 versus 7 months (p value = 0.46). The median overall survival (OS) in all the patients who have received adjuvant therapy was 23 months (16.6–29.4); the median OS in the adjuvant CRT was 20 months, whereas the overall survival estimate of the adjuvant CT group did not reach the median (p value 0.62) with a hazard ratio was 1.5 (0.32–6.7).

Conclusion:

Adjuvant CT given after surgery for pancreatic cancer offered 3-months improvement in DFS when compared with adjuvant CRT in Saudi population treated at KFSHRCJ. However, this improvement did not translate into a statistically significant difference in DFS or OS.

Gastrointest Cancer Res. 2014 Sep;7(4 Suppl 1):S19–S20.

nab-Paclitaxel (nab-P) Plus Gemcitabine (Gem) vs. Gem Alone for Resected Pancreatic Cancer (PC) in a Phase III Trial (APACT)

Margaret A Tempero 1, Dana Cardin 2, Andrew Biankin 3, David Goldstein 4, Malcolm Moore 5, Eileen M O'Reilly 6, Philip Philip 7, Hanno Riess 8, Teresa Macarulla 9, Lotus Yung 10, Xinyu Wei 10, Brian Lu 10

ABSTR 1417 – Poster Presentation

Background:

Gem monotherapy after surgery improves both survival rates and disease-free survival (DFS) in patients with PC. However, disease recurrence is common, suggesting a need for improved treatment. nab-P + Gem demonstrated superior efficacy over Gem alone in a phase III trial (MPACT) of patients with metastatic PC, including the primary endpoint of overall survival (OS; 8.7 vs. 6.6 months; hazard ratio [HR] 0.72; P < 0.001]). Toxicities were manageable. Based on the activity demonstrated in the metastatic setting, nab-P + Gem will be compared with Gem alone in the adjuvant setting.

Trial design:

Approximately 800 patients with histologically confirmed PC who undergo macroscopic complete resection (R0 or R1), with no evidence of metastasis, will be randomized 1:1 to receive 6 cycles of either nab-P 125 mg/m2 plus Gem 1000 mg/m2 or Gem alone 1000 mg/m2 on days 1, 8, and 15 of each 28-day cycle. Other eligibility criteria include staging of T1-3, N0-1, M0; Eastern Cooperative Oncology Group performance status of 0 or 1; acceptable hematologic function; carbohydrate antigen 19-9 < 100 U/mL prior to randomization; and no prior neoadjuvant therapy or radiation for pancreatic ductal adenocarcinoma. Patients with neuroendocrine tumors, any other malignancy within 5 years of randomization, infection with human immunodeficiency virus or hepatitis B or C, or prior neoadjuvant treatment or radiation therapy for PC are ineligible. Stratification factors are resection status (R0 vs. R1), nodal status (LN+ vs. LN−), and geographic region (North America, Europe, and Australia vs. Asia Pacific). The primary endpoint is independently assessed DFS, and secondary endpoints are OS and safety. Exploratory endpoints include molecular profiling of tumor tissue to correlate tumor heterogeneity with clinical outcome and quality of life as assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaires-C30 and -PAN26. The planned enrollment of 800 patients will allow 90% power to detect an HR for DFS of 0.74 at a 2-sided significance level of 0.05. One interim safety analysis and 2 interim efficacy analyses (the first for futility and the second for both futility and efficacy) will be performed. Patient enrollment is ongoing (ClinicalTrials.gov identifier NCT01964430).

Conclusions:

This phase III trial will determine whether nab-P + Gem is superior to Gem alone as adjuvant treatment for patients with PC. Such findings would establish nab-P + Gem as a new standard therapy in this disease setting.

Articles from Gastrointestinal Cancer Research : GCR are provided here courtesy of International Society of Gastrointestinal Oncology

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