Concurrent chemoradiotherapy of patients with locally advanced squamous cell carcinoma of the oral cavity (stage III, IV)

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e17034-e17034
Author(s):  
D. G. Adilbay ◽  
G. B. Adilbaev ◽  
D. N. Ahmetov
Keyword(s):  
Oral Cavity ◽  
Head And Neck ◽  
Concurrent Chemoradiotherapy ◽  
Locally Advanced ◽  
Disease Free Survival ◽  
Clinical Effects ◽  
Free Survival ◽  
Conventional Fractionation ◽  
Altered Fractionation ◽  
Grade 3

e17034 Background: Randomized trials have showed a good result of concurrent chemoradiotherapy in advanced SCC of the head and neck. But there are only few trials which evaluates separately the different sites of the head and neck. The aim was to evaluate the toxicity and efficacy of concurrent intra-arterial chemotherapy plus radiotherapy with altered fractionation in SCC of the oral cavity. Methods: 43 patients with previously untreated oral cavity SCC (T3–4N0–2M0) received concurrent chemoradiotherapy by followed scheme: first day intra-arterial chemotherapy: docetaxel - 80 mg/m2, cysplatin - 100 mg/m2, from second to 21st day RT (28 Gy by 4 Gy - 3 times week), 22nd day second course of intra-arterial chemotherapy and after RT (total dose- 60 Gy by 2 Gy 5 times week, total equivalent to 70Gy by conventional fractionation), depending on the results salvage surgery if necessary. Results: The clinical effects were pCR in 34 (79.1%) patients, pPR in 9 (20.9%) patients. The following main toxicities of chemoradiotherapy were observed: only 2 cases of grade 3 neutropenia, Non-hemathologic toxicity: 74.4% (32 patients) grade 3 mucosal events. All patients have totally completed the treatment. The 3-year overall survival rate were 83.7%, and 3-year disease free survival were 76.7%. Conclusions: This regimen of concurrent chemoradiotherapy where radiotherapy is used by altered fractionation is feasible, safe and well tolerated. No significant financial relationships to disclose.

Role of concurrent chemoradiotherapy in organ preservation for locally advanced head and neck cancer

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e17044-e17044
Author(s):  
N. Savaraj ◽  
V. Dinh ◽  
L. Chua ◽  
P. Bustillo ◽  
K. Nissim
Keyword(s):  
Head And Neck Cancer ◽  
Head And Neck ◽  
Neck Cancer ◽  
Concurrent Chemoradiotherapy ◽  
Locally Advanced ◽  
Disease Free Survival ◽  
Hypopharyngeal Cancer ◽  
Advanced Head ◽  
Free Survival ◽  
Disease Free

e17044 Background: Optimal management for head and neck cancer is controversial. Standard of care has been surgery followed by radiotherapy, but is done with the risk of organ resection. The VA larynx study, EORTC 24891, and 91–11 US Intergroup trial have shown that chemoradiotherapy is comparable to surgery with radiotherapy in laryngeal cancers while preserving organ function. It is unclear, though, whether this could be accomplished in other tumor sites without sacrificing locoregional control and/or survival. Methods: We performed a retrospective chart review of patients who were treated at the Miami VA Medical Center with chemoradiotherapy for advanced staged head and neck cancers from 1996 to 2008. The majority of patients (84%) received 5FU and cisplatin. The choice of chemoradiotherapy was either determined by patients’ choice or their comorbidities, such as pulmonary disease and cardiac disease, precluded them from undergoing major surgery. Primary endpoints included death, relapse rates, and disease-free survival; secondary endpoints were toxicities associated with treatment and diminished organ function. Results: A total of 62 patients were included. Out of these patients, 52% had stage III disease and 50% had primary sites in the oropharynx; the remaining included larynx and hypopharynx. 20% of patients required salvage neck dissection. Complications included severe mucositis (69%), dysphagia (19% short term, 34% long term), hoarseness (13%), and dry mouth (24%). 27% had relapse of disease and median time for disease-free survival was 26 months. A total of 35 patients had died with a 2-year survival rate of 59.6%. Overall survival was best for laryngeal and oropharyngeal cancer (63 and 46 months, respectively) compared to hypopharyngeal cancer (22 months). Conclusions: Concurrent chemoradiotherapy is a valid option for treatment of locally advanced head and neck cancers especially for laryngeal and possibly oropharyngeal primaries with significant but tolerable toxicities. Although organ preservation is possible for the majority of patients with locally advanced head and neck cancer, however, the poor survival seen in hypopharyngeal cancer needs further investigation. No significant financial relationships to disclose.

scholarly journals Improved Overall Survival and Decreased Metastasis With Adjuvant 5-Fluorouracil and Platinum Chemotherapy After Definitive Concurrent Chemoradiotherapy for N3 Nasopharyngeal Cancer: A Registry-Based Analysis

2021 ◽  
Author(s):  
Mu-Hung Tsai ◽  
Shang-Yin Wu ◽  
Tsung Yu ◽  
Sen-Tien Tsai ◽  
Yuan-Hua Wu
Keyword(s):  
Overall Survival ◽  
Prognostic Factors ◽  
Adjuvant Chemotherapy ◽  
Distant Metastasis ◽  
Concurrent Chemoradiotherapy ◽  
Locally Advanced ◽  
Nasopharyngeal Cancer ◽  
Disease Free Survival ◽  
Free Survival ◽  
Risk Of Death

Abstract Background and purpose Concurrent chemoradiotherapy is the established treatment for locally advanced nasopharyngeal carcinoma (NPC). However, there is no evidence supporting routine adjuvant chemotherapy. We aimed to demonstrate the effect of adjuvant chemotherapy on survival and distant metastasis in high-risk N3 NPC patients. Materials and methods We linked the Taiwan Cancer Registry and Cause of Death database to obtain data. Clinical N3 NPC patients were divided as those receiving definitive concurrent chemoradiotherapy (CCRT) with adjuvant 5-fluorouracil and platinum (PF) chemotherapy and those receiving no chemotherapy after CCRT. Patients receiving neoadjuvant chemotherapy were excluded. We compared overall survival, disease-free survival, local control, and distant metastasis in both groups using Cox proportional hazards regression analysis. Results We included 431 patients (152 and 279 patients in the adjuvant PF and observation groups, respectively). Median follow-up was 4.3 years. The 5-year overall survival were 69.1% and 57.4% in the adjuvant PF chemotherapy and observation groups, respectively (p = 0.02). Adjuvant PF chemotherapy was associated with a lower risk of death (hazard ratio [HR] = 0.61, 95% confidence interval [CI]: 0.43–0.84; p = 0.003), even after adjusting for baseline prognostic factors (HR = 0.61, 95% CI: 0.43–0.86; p = 0.005). Distant metastasis-free survival at 12 months was higher in the adjuvant PF chemotherapy group than in the observation group (98% vs 84.8%; p < 0.001). After adjusting for baseline prognostic factors, adjuvant PF chemotherapy was associated with freedom from distant metastasis (HR = 0.11, 95% CI: 0.02–0.46; p = 0.003). Conclusion Prospective evaluation of adjuvant PF chemotherapy in N3 NPC patients treated with definitive CCRT is warranted because adjuvant PF chemotherapy was associated with improved overall survival and decreased risk of distant metastasis.

scholarly journals Phase III Randomized Trial of Induction Chemotherapy in Patients With N2 or N3 Locally Advanced Head and Neck Cancer

2014 ◽  
Vol 32 (25) ◽  
pp. 2735-2743 ◽  
Author(s):  
Ezra E.W. Cohen ◽  
Theodore G. Karrison ◽  
Masha Kocherginsky ◽  
Jeffrey Mueller ◽  
Robyn Egan ◽  
...  
Keyword(s):  
Head And Neck ◽  
Induction Chemotherapy ◽  
Locally Advanced ◽  
Phase Iii ◽  
Serious Adverse Events ◽  
Free Survival ◽  
Distant Failure ◽  
Common Grade ◽  
Treatment Naïve ◽  
Grade 3

Purpose Induction chemotherapy (IC) before radiotherapy lowers distant failure (DF) rates in locally advanced squamous cell carcinoma of the head and neck (SCCHN). The goal of this phase III trial was to determine whether IC before chemoradiotherapy (CRT) further improves survival compared with CRT alone in patients with N2 or N3 disease. Patients and Methods Treatment-naive patients with nonmetastatic N2 or N3 SCCHN were randomly assigned to CRT alone (CRT arm; docetaxel, fluorouracil, and hydroxyurea plus radiotherapy 0.15 Gy twice per day every other week) versus two 21-day cycles of IC (docetaxel 75 mg/m2 on day 1, cisplatin 75 mg/m2 on day 1, and fluorouracil 750 mg/m2 on days 1 to 5) followed by the same CRT regimen (IC + CRT arm). The primary end point was overall survival (OS). Secondary end points included DF-free survival, failure pattern, and recurrence-free survival (RFS). Results A total of 285 patients were randomly assigned. The most common grade 3 to 4 toxicities during IC were febrile neutropenia (11%) and mucositis (9%); during CRT (both arms combined), they were mucositis (49%), dermatitis (21%), and leukopenia (18%). Serious adverse events were more common in the IC arm (47% v 28%; P = .002). With a minimum follow-up of 30 months, there were no statistically significant differences in OS (hazard ratio, 0.91; 95% CI, 0.59 to 1.41), RFS, or DF-free survival. Conclusion IC did not translate into improved OS compared with CRT alone. However, the study was underpowered because it did not meet the planned accrual target, and OS was higher than predicted in both arms. IC cannot be recommended routinely in patients with N2 or N3 locally advanced SCCHN.

Adjuvant chemotherapy with S-1 after curative treatment in patients with head and neck cancer (ACTS-HNC).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 6004-6004 ◽  
Author(s):  
Takahide Taguchi ◽  
Akira Kubota ◽  
Kunitoshi Yoshino ◽  
Kichinobu Tomita ◽  
Naoyuki Kohno ◽  
...  
Keyword(s):  
Adjuvant Chemotherapy ◽  
Head And Neck ◽  
Disease Free Survival ◽  
Phase Iii ◽  
Curative Treatment ◽  
Free Survival ◽  
End Point ◽  
Phase Iii Study ◽  
P 16 ◽  
Grade 3

6004 Background: To establish the efficacy of adjuvant chemotherapy with S-1 (tegafur gimeracil oteracil potassium) after curative treatment in patients with advanced squamous cell carcinoma of the head and neck (SCCHN), we conducted a randomized phase III study to investigate whether S-1 is superior to UFT (uracil/tegafur). Methods: Patients with SCCHN who had received curative treatment and were confirmed to be tumor-free were randomly assigned to receive UFT (300 or 400 mg/day for 1 year) or S-1 (80, 100, or 120 mg/day for 1 year). The primary end point was disease-free survival (DFS). Secondary end points were overall survival (OS), relapse-free survival (RFS), and safety. We estimated that 500 patients were needed to establish the primary end point. Results: From April 2006 through November 2008, a total of 526 patients (262 assigned to UFT; 264 assigned to S-1) were enrolled. The 3-year DFS rate was 66.0% in the UFT group and 64.1% in the S-1 group (hazard ratio [HR], 0.87; 95% confidence interval [CI], 0.66 to 1.16; [log-rank], P = .34). The 3-year OS rate was 75% in the UFT group and 82.9% in the S-1 group (HR, 0.64; 95% CI, 0.44 to 0.94; [log-rank], P = .022). The 3-year RFS rate was 63.6% in the UFT group and 68.2% in the S-1 group (HR, 0.81; 95% CI, 0.60 to 1.09; [log-rank], P = .16). There were no significant differences in 3-year DFS or RFS; however, the 3-year OS was significantly better in the S-1 group. The incidence of the following grade 3 or 4 events was significantly higher in the S-1 group: oral mucositis/stomatitis (2.4%), leukopenia (5.2%), neutropenia (3.6%), and thrombocytopenia (5.0%). Conclusions: S-1 was not demonstrated to be superior to UFT in terms of 3-year DFS; however, 3-year OS was significantly better with S-1 than with UFT. Clinical trial information: NCT00336947.

Impact of antiviral prophylaxis in HSV positive patients treated with concurrent chemoradiotherapy for head and neck cancer.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 6078-6078
Author(s):  
Nathalie Letarte ◽  
Vincent-T. Taillefer ◽  
Céline Marty ◽  
Louise Lambert ◽  
Francine Aubin ◽  
...  
Keyword(s):  
Head And Neck Cancer ◽  
Head And Neck ◽  
Neck Cancer ◽  
Concurrent Chemoradiotherapy ◽  
Locally Advanced ◽  
Control Group ◽  
Antiviral Prophylaxis ◽  
Grade 3 ◽  
Simplex Virus ◽  
The Impact

6078 Background: Chemoradiotherapy used for the treatment of locally advanced head and neck cancer (HNC) causes a high incidence of mucositis that may be accentuated by a reactivation of herpes simplex virus (HSV). To date, no study has evaluated the impact of antivirals used as prophylaxis to prevent mucositis or their severity. Methods: This is a retrospective observational study including patients who received at least one cycle of concurrent chemoradiotherapy for the treatment of head and neck cancer between January 2014 and June 2017 at the Centre hospitalier de l’Université de Montréal (CHUM). HSV negative patients were excluded. After approval by the IRB, we compared the incidence and severity of mucositis in HSV positive patients who started an antiviral prophylaxis before cycle 1 or 2 (prophylaxis group) to HSV+/unknown HSV patients who did not receive antiviral prophylaxis (control group). Emergency visits and hospitalizations related to mucositis were collected. Mucositis were assessed regularly by radiation oncologists during the treatment. Results: Of 482 patients who received concurrent chemoradiotherapy for HNC, 75 were HSV negative and 407 were included in this study. In the group with (n = 94) and without prophylaxis (n = 313), patients received carboplatin and 5-FU (77% vs 62%) and cisplatin (23% vs 38%) with concurrent radiation respectively. The rate of all grade mucositis in patients with and without prophylaxis (99% vs 96%; p = 0.19) was not statistically significant. The rate of grade 3 and 4 mucositis (42% vs 49%; p = 0.29), the rate of emergency visit (29% vs 28%; p = 0.91) and hospitalization (9% vs 8%; p = 0.80) were not statistically significant between each group. However, in a subgroup of patient receiving carboplatin and 5-FU, antiviral prophylaxis seems to decrease significantly the rate of grade 3 (49% vs 63%; p = 0.04). Conclusions: The addition of antiviral prophylaxis in HSV positive in patients undergoing concurrent chemoradiotherapy for locally advanced HNC didn’t decrease the rate of all grade mucositis. In the subgroup of patients receiving carboplatin and 5-FU mainly of oropharynx origin, HSV prophylaxis decreased the severity of mucositis.

scholarly journals Early Postoperative Paclitaxel Followed by Concurrent Paclitaxel and Cisplatin With Radiation Therapy for Patients With Resected High-Risk Head and Neck Squamous Cell Carcinoma: Report of the Phase II Trial RTOG 0024

2009 ◽  
Vol 27 (28) ◽  
pp. 4727-4732 ◽  
Author(s):  
David I. Rosenthal ◽  
Jonathan Harris ◽  
Arlene A. Forastiere ◽  
Randal S. Weber ◽  
John A. Ridge ◽  
...  
Keyword(s):  
Radiation Therapy ◽  
High Risk ◽  
Head And Neck ◽  
Squamous Cell ◽  
Concurrent Chemoradiotherapy ◽  
Disease Free Survival ◽  
Locoregional Control ◽  
Free Survival ◽  
Positive Margins ◽  
Disease Free

Purpose We sought to improve outcomes for patients with high-risk head and neck squamous cell cancer (HNSCC) after surgical resection by testing the feasibility and safety of early postoperative chemotherapy followed by concurrent chemoradiotherapy. Patients and Methods Eligible patients had resected, stages III to IV HNSCC with positive margins, extracapsular nodal extension, or multiple positive nodes. Paclitaxel (80 mg/m2) was given once weekly during postoperative weeks 2, 3, and 4 and was given before radiation therapy (RT). Paclitaxel (30 mg/m2) and cisplatin (20 mg/m2) were given once weekly during the last 3 weeks of RT (60 Gy over 6 weeks, beginning 4 to 5 weeks after surgery). The primary end points were treatment safety and tolerability compared with concurrent cisplatin (100 mg/m2 every 3 weeks) and RT, as tested in Radiation Therapy Oncology Group trial RTOG 9501. Results The median follow-up time for the 70 patients enrolled was 3.3 years (range, 0.6 to 4.4 years) for surviving patients. Tolerability of all treatment components was comparable to that of RTOG 9501 treatment, which is the current standard of care (compliance rate, 75%; 95% CI, 63% to 85%). One patient died, and seven patients experienced grade 4 nonhematologic toxicities. Rates of locoregional control, disease-free survival, and overall survival exceeded those of RTOG 9501 after adjustment for important prognostic variables (ie, positive margins, extracapsular extension, primary site, and performance status). Conclusion Chemotherapy soon after surgery followed by concurrent chemoradiotherapy therapy was feasible; tolerance was in line with standard postoperative chemoradiotherapy; and this regimen led to excellent rates of locoregional control and disease-free survival.

scholarly journals The Influence of Cisplatin Dose upon Survival in Concurrent Chemoradiotherapy of Locally Advanced Cervical Carcinoma with Weekly Cisplatin

2008 ◽  
Vol 51 (2) ◽  
pp. 95-99 ◽  
Author(s):  
Igor Sirák ◽  
Jiří Petera ◽  
Zdeněk Zoul
Keyword(s):  
Overall Survival ◽  
Cervical Carcinoma ◽  
Concurrent Chemoradiotherapy ◽  
Locally Advanced ◽  
Disease Free Survival ◽  
Hematological Toxicity ◽  
High Dose ◽  
Free Survival ◽  
Disease Free ◽  
Weekly Cisplatin

The objective of this study was to evaluate the influence of cisplatin dose upon 3-year overall and disease-free survival rate of patients with advanced cervical cancer treated with concurrent chemoradiotherapy with weekly cisplatin. Seventy-three patients with stage IIB – IVA cervical carcinoma were treated with pelvic (or pelvic + paraaortic) externalbeam radiotherapy, high-dose rate brachytherapy and concomitant chemotherapy with weekly cisplatin of 40 mg/m2 in the time period form January 2000 to December 2006 at our department. The 3-year overall survival and disease-free suvival rates were evaluated with regard to the number of cisplatin cycles applied during the external radiotherapy. Only twentyeight patients received the intended five doses of chemotherapy. The most frequent cause of chemotherapy delay was the acute hematological toxicity with leukopenia. The 3-year overall survival was 71 % and the 3-year disease-free survival was 61 %. Survival analyses didn’t prove a statistically significant influence of cisplatin dose upon 3-year survival in cervical carcinoma patients treated by exclusive chemoradiation with weekly cisplatin.

Compliance, toxicity and efficacy in weekly versus 3-weekly cisplatin concurrent chemoradiation in locally advanced head and neck cancer

2018 ◽  
Vol 18 (1) ◽  
pp. 21-25 ◽  
Author(s):  
Sandeep Muzumder ◽  
Nirmala Srikantia ◽  
Ganesha Dev Vashishta ◽  
Avinash H. Udayashankar ◽  
John Michael Raj ◽  
...  
Keyword(s):  
Head And Neck Cancer ◽  
Head And Neck ◽  
Neck Cancer ◽  
Locally Advanced ◽  
Disease Free Survival ◽  
Concurrent Chemoradiation ◽  
Advanced Head ◽  
Flat Dose ◽  
Grade 3 ◽  
Weekly Cisplatin

AbstractAimWeekly low-dose cisplatin is routinely used in concurrent chemoradiation (CCRT) in locally advanced head and neck cancer (LAHNC), despite 3-weekly cisplatin being the standard of care. We compared compliance, toxicity and efficacy in weekly versus 3-weekly cisplatin CCRT in LAHNC.Materials and methodsIn this retrospective study, weekly cisplatin 50 mg flat dose was compared with 3-weekly cisplatin 100 mg/m2, when given in CCRT in LAHNC with curative intent. The study outcome was compliance, toxicity, loco-regional control (LRC), disease-free survival (DFS) and overall survival (OS).ResultsEighty-four patients received CCRT from January 2013 to June 2017, 40 in weekly and 44 in 3-weekly arm. There was no difference between the arms not completing scheduled radiation therapy or chemotherapy. Patient receiving 200 mg/m2 cisplatin is higher in 3-weekly arm compared with weekly arm (75 versus 40·9%; p<0·0015). Compared with 3-weekly arm, more patient in weekly arm developed grade ≥3 mucositis (52·5 versus 15·9%, p=0·0004), day care intravenous hydration (82·5 versus 38·6% <0·0001) and in-patient admission (55·0 versus 18·2%; p=0·0004). The 2-year LRC, DFS and OS in weekly versus 3-weekly arm were: 70 versus 61·4% (p=0·406); 67·5 versus 56·8% (p=0·314); 67·5 versus 61·4% (p=0·558), respectively. The median time to LRR, DFs and OS was not reached.ConclusionsWeekly cisplatin is comparable with 3-weekly cisplatin in terms of compliance, disease control and survival, but with increased grade 3 mucositis and higher admissions for supportive care.

LUX-head and neck 2: Randomized, double-blind, placebo-controlled, phase III trial of afatinib as adjuvant therapy after chemoradiation (CRT) in primary unresected, high/intermediate-risk, squamous cell cancer of the head and neck (HNSCC) patients (pts).

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 6001-6001 ◽  
Author(s):  
Barbara Burtness ◽  
Robert I. Haddad ◽  
José Dinis ◽  
Jose Manuel Trigo Perez ◽  
Tomoya Yokota ◽  
...  
Keyword(s):  
Oral Cavity ◽  
Head And Neck ◽  
Cell Cancer ◽  
Locally Advanced ◽  
Disease Free Survival ◽  
Phase Iii ◽  
Phase Iii Trial ◽  
Egfr Inhibition ◽  
N2 Disease ◽  
Ecog Ps

6001 Background: Locally advanced HNSCC is treated curatively, but recurrence is common. In HNSCC, EGFR is richly expressed and EGFR inhibition is validated treatment (tx); the ErbB family blocker afatinib (A) showed efficacy in recurrent/metastatic disease. This Phase III trial assessed if A after definitive CRT improves disease-free survival (DFS). Methods: Eligible pts had complete response after CRT ≥66 Gy (or equivalent) with concurrent cisplatin or carboplatin but not prior EGFR inhibition, for HNSCC of oral cavity, hypopharynx, larynx, or oropharynx with >10 pack years (pk yrs) tobacco use. Pts were stratified by ECOG PS (0/1) and nodal stage (N0–2a/N2b–3), and randomized 2:1 to A 40 mg/d or placebo (P); tx continued for 18 m if tolerated, or until disease recurrence. The primary endpoint was DFS. Results: Of 669 pts planned, 617 were randomized; A 411, P 206. Median age was 58 yrs; 86% were male; 65% ECOG PS 0; most had smoked (A/P ex-smoker: 66/72%; current: 28/22%). Subsites (A/P) were: oropharynx 53/54%; hypopharynx 21/23%; larynx 18/12%; oral cavity 9/10%. The majority had T3 or 4 (A/P 70/68%) and N2 disease (67/63%). Accrual was halted for futility on independent DMC recommendation: at a pre-planned interim analysis (40% of DFS events), median DFS was A 43.4 m vs P not reached (NR; HR 1.13 [95% CI 0.81–1.57], p=0.48); the Table shows key subgroups. Median treatment duration was A 300.0 d, P 455.5 d. Recurrence was A 23%, P 23%. Dose reduction of A was required in 53% (mostly due to diarrhea, stomatitis). Tx was discontinued due to AEs in A 15%, P 4%. Conclusions: A after CRT did not improve DFS vs P. Subgroup analyses were underpowered to provide definitive conclusions. Harrington and Cohen contributed equally. Clinical trial information: NCT01345669. [Table: see text]

Adjuvant FOLFOX + nab-paclitaxel (FOLFOX-A)for pancreatic cancer, BrUOG 278: A Brown University oncology research group phase II study.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e15733-e15733
Author(s):  
Howard Safran ◽  
Kevin Charpentier ◽  
Rimini Breakstone ◽  
John Vatkevich ◽  
Celine Hamel ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Phase Ii ◽  
Research Group ◽  
Locally Advanced ◽  
Disease Free Survival ◽  
Free Survival ◽  
Oncology Research ◽  
Brown University ◽  
Grade 3 ◽  
Disease Free

e15733 Background: Adjuvant FOLFIRINOX increases survival in pancreatic cancer but is associated with significant toxicity. The Brown University Oncology Research Group (BrUOG) developed the FOLFOX-A regimen in a phase I study in advanced pancreatic cancer (Am J Clin Oncol, 2016). Phase II studies (BrUOG 292 and BrUOG 318) have shown substantial activity in patients with metastatic and locally advanced disease. Highly active regimens have the potential to improve survival in the adjuvant setting. The primary objective of BrUOG 295 was to determine the feasibility of administering 10 cycles of FOLFOX-A. Secondary objectives were toxicity and disease free survival. Methods: Patients received oxaliplatin, 85mg/m2 day 1, nab-paclitaxel, 150mg/m2 and leucovorin 400mg/m2 day 1 and fluorouracil 2400mg/m2 by continuous IV infusion over 46 hours. Myeloid growth factor support was optional. Cycles were repeated every 14 days for up to 10. Oxaliplatin was dose reduced to 68mg/m2 for grade 2 neurotoxicity. CTCAE version 4 toxicity scales were utilized. Results: The study reached its initial accrual goal of 25 patients. The median age was 60 (43-69). Twenty-one patients were node +. Twelve of the first 20 patients have received 10 cycles of FOLFOX-A and 17 of the first 20 patients received > 8 cycles. The most common grade >3 toxicities were neutropenia grade 3 (N = 3), grade 4 (N = 3) and fatigue grade 3 (n = 13). One patient had grade 3 neuropathy. Conclusions: Adjuvant FOLFOX-A is well tolerated with low incidences of grade 3 neuropathy and gastrointestinal toxicity. Toxicity, feasibility and disease free survival will be updated at the May 2019 BrUOG DSMB meeting. Clinical trial information: NCT02022033.

Sign in / Sign up

Export Citation Format

Share Document