Next-generation sequencing (NGS) in metastatic gastrointestinal cancer (mGIC) patients: Translation from sequence data into clinical practice.

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 72-72 ◽  
Author(s):  
Raphael Brandao Moreira ◽  
Matheus Bongers Alessandretti ◽  
Carina Mina Abrahao ◽  
Aline Da Rocha Lino ◽  
Tarcia Tarciane Soares de Sousa ◽  
...  
Keyword(s):  
Targeted Therapy ◽  
Gastrointestinal Cancer ◽  
Sequence Data ◽  
Performance Status ◽  
Objective Response ◽  
Genetic Alterations ◽  
Mitogen Activated Protein Kinase ◽  
Primary Tumors ◽  
Mutational Profiling ◽  
Number Of Patients

72 Background: A considerable number of patients with mGIC progress after exhausting all approved standard therapies but maintain an adequate performance status and could be candidates for further treatment. We aim at reviewing our experience with the use of a NGS platform in refractory mGIC and its clinical utility. Methods: We retrospectively reviewed demographics, NGS results, and the suggested therapies received by patients undergoing NGS (Foundation Medicine, Cambridge, MA, USA): exonic sequencing of 236 genes and selective intronic sequencing from 19 genes for refractory mGIC. Co-primary endpoints were the percentage of patients with targeted therapy options uncovered by mutational profiling and the percentage of them who received genotype-directed therapy. Results: Samples from 32 patients were tested. Primary tumors consisted of colorectal adenocarcinoma (37,5%), pancreatic adenocarcinoma (31,2%), gastric adenocarcinoma (12,5%), cholangiocarcinoma (12,5%) and hepatocellular carcinoma (6%). Most patients (87,5%) were found to harbor potentially actionable genetic alterations involving mitogen-activated protein kinase (93,7%), phosphatidylinositol 3-kinase-AKT (18,7%), p53 (50%) and cell-cycle regulation (9%) pathways. Of the 6 patients who received the suggested targeted therapy, 4 achieved an objective response. Conclusions: Mutational profiling using a targeted NGS panel identified potentially actionable alterations in the majority of advanced gastrointestinal cancer patients. The assay provided clinical benefit in 12% of the patients.

Next-generation sequencing (NGS) in metastatic breast cancer (mBC) patients: Translation from sequence data into clinical practice.

2015 ◽  
Vol 33 (28_suppl) ◽  
pp. 133-133 ◽  
Author(s):  
Raphael Brandao Moreira ◽  
Renata Peixoto ◽  
Tercia Tarciane Soares de Sousa ◽  
Marcelo Cruz ◽  
Fernando Maluf ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Targeted Therapy ◽  
Sequence Data ◽  
Objective Response ◽  
Metastatic Breast ◽  
Genomic Alteration ◽  
Histologic Subtype ◽  
Mutational Profiling ◽  
Number Of Patients ◽  
Her 2

133 Background: A considerable number of patients with mBC progress after exhausting all approved standard therapies but maintain an adequate performance status and could be candidates for further treatment. We aim at reviewing our experience with the use of a NGS platform in refractory mBC and its clinical utility. Methods: We retrospectively reviewed demographics, NGS results, and the suggested therapies received by patients undergoing NGS (Foundation Medicine, Cambridge, MA, USA): exonic sequencing of 315 genes and selective intronic sequencing from 28 genes for refractory mBC. Co-primary endpoints were the percentage of patients with targeted therapy options uncovered by mutational profiling and the percentage of them who received genotype-directed therapy. Results: Samples from 20 patients were tested. Histologic subtype consisted of triple negative (50%), HER 2 +, hormonal receptor [HR] - 15%, HR + and HER 2 - (35%). A targetable genomic alteration was identified in 14 (70%) patients, most frequently in TP53 (11 [55%]), PIK3CA (8 [40%]), FGFR1 (4 [20%]), CCND1 (3 [15%]), PTEN (3[15%]) and BRCA2 (2[10%]). Therapy could be personalized in 9 (45%) of 14 patients. Of the 9 patients who were received targeted therapy, 7 (77%) had an objective response and had stable disease for more than 3 months. Conclusions: Mutational profiling using a targeted NGS panel identified potentially actionable alterations in the majority of advanced breast cancer patients. The assay provided clinical benefit in 35% of the patients.

A multicentered population-based analysis of outcomes of patients with metastatic renal cell carcinoma (mRCC) who do not meet eligibility criteria for clinical trials.

2012 ◽  
Vol 30 (5_suppl) ◽  
pp. 353-353 ◽  
Author(s):  
Daniel Yick Chin Heng ◽  
Toni K. Choueiri ◽  
Jae-Lyun Lee ◽  
Lauren Christine Harshman ◽  
Georg A. Bjarnason ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Targeted Therapy ◽  
Brain Metastases ◽  
Clear Cell ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
Progression Free Survival ◽  
Exclusion Criteria ◽  
Eligibility Criteria ◽  
Number Of Patients

353 Background: Clinical trials have strict eligibility criteria to maintain internal validity. These criteria exclude many patients to whom the trial results are later applied to in clinical practice. Patients that do not meet eligibility criteria are poorly characterized. Methods: mRCC patients treated with VEGF targeted therapy were retrospectively deemed ineligible for clinical trials (according to commonly used inclusion/exclusion criteria) if they had a Karnofsky Performance Status (KPS) < 70%, brain metastases, non-clear cell histology, hemoglobin ≤ 9 g/dL, creatinine > 2x the upper limit of normal, platelet count of < 100x103/uL, neutrophil count < 1500/mm3 or corrected calcium ≤ 12 mg/dL. Results: 894/2076 (43%) patients were deemed ineligible for clinical trials by the above criteria. Between ineligible versus eligible patients, the response rate, median progression free survival (PFS) and median overall survival of first-line targeted therapy were 21% vs 29%, 5.2 vs 8.8 months and 14.5 vs 28.8 months (all p < 0.0001), respectively. Second-line PFS (if applicable) was 3.2 months in the trial ineligible vs 4.4 months in the trial eligible patients (p = 0.0074). When adjusted by the Heng et al prognostic categories, the hazard ratio for death between trial ineligible vs trial eligible patients was 1.621 (95% CI = 1.431–1.836, p < 0.0001). If only KPS, brain metastases and non-clear cell histology were used as exclusion criteria, 672 (32%) patients were excluded and the results were similar. Conclusions: The number of patients that are ineligible for clinical trials is high and their outcomes are inferior. Designing more inclusive clinical trials for this “ineligible” patient population are needed. [Table: see text]

scholarly journals Clinical Response to Sorafenib in a Patient with Metastatic Colorectal Cancer and FLT3 Amplification

2015 ◽  
Vol 8 (1) ◽  
pp. 83-87 ◽  
Author(s):  
Raphael Brandão Moreira ◽  
Renata D''Alpino Peixoto ◽  
Marcelo Rocha de Sousa Cruz
Keyword(s):  
Colorectal Cancer ◽  
Targeted Therapy ◽  
Metastatic Colorectal Cancer ◽  
Clinical Response ◽  
Performance Status ◽  
Colorectal Tumor ◽  
Sorafenib Treatment ◽  
Flt3 Mutation ◽  
Number Of Patients

Background: A considerable number of patients with metastatic colorectal cancer progress after exhausting all approved standard therapies but maintain an adequate performance status and could be candidates for further treatment. We aim at reviewing our experience with sorafenib treatment of a patient with FLT3 mutation in refractory metastatic colorectal cancer. Methods: Treatment with sorafenib of a patient with metastatic colorectal cancer and FLT3 translocation who had previously been heavily treated. Results: The patient with metastatic colorectal cancer, aged 51 years, showed significant symptomatic and laboratory improvement with sorafenib treatment (400 mg twice daily). Conclusion: The presented case illustrates how an aggressive and refractory colorectal tumor may respond well to targeted therapy.

Presence of genetic aberrations in patients with brain metastases from non-small cell lung cancer (NSCLC) and clinical outcomes.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e20604-e20604 ◽  
Author(s):  
Robert H. Press ◽  
Xinyan Zhang ◽  
Richard John Cassidy ◽  
Matthew Jeffrey Ferris ◽  
Jim Zhong ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Targeted Therapy ◽  
Brain Metastases ◽  
Clinical Outcomes ◽  
Performance Status ◽  
Multivariable Analysis ◽  
Genetic Alterations ◽  
Kras Mutations ◽  
Brain Radiotherapy ◽  
Systemic Therapies

e20604 Background: Historically, survival in patients (pts) with NSCLC brain metastases (BM) is poor, however, improved systemic therapies are now available including targeted therapies and immunotherapy. We sought to evaluate the prevalence of genetic alterations in pts with BM from non-squamous (NS) lung cancer, and to determine clinical outcomes in the modern era. Methods: With IRB approval, pts with BM from NS-NSCLC from 1/2010-1/2016 with genetic testing were captured and retrospectively reviewed. Snapshot genotyping was performed prior to 1/2014, after which Next Generation Sequencing was utilized, along with FISH lung cancer panel. Genes examined included: EGFR, ALK, RET, ROS1, TP53, KRAS, NRAS, MET, PTEN, BRAF, FBXW7, MAP2K1, APC, PIK3CA, CTNNB1, and SMAD4. Univariable and multivariable analysis (MVA) were utilized to assess factors associated with overall survival (OS). Results: 92 pts were included. Median number of BM was 4 (range 1-45). Median age was 64 (32-90 years). 59.8% were male. 38% received targeted therapy, 11% received immunotherapy, and 70% received conventional chemotherapy. 52.2% and 47.8% received whole brain radiotherapy and stereotactic radiosurgery, respectively. Median OS from first brain radiotherapy (RT) was 10.7 months (0.1-56.4). EGFR mutation, ALK fusion, ROS1 rearrangement, and RET rearrangement occurred in 27.5%, 5.2%, 1.7%, and 0% of pts. EGFR L858 and EGFR T790 mutations occurred in 19.2% and 2.7% of all pts. TP53, KRAS, and NRAS mutations occurred in 63.9%, 28.8% and 7% of pts. All other mutations had an incidence of less than 3%. On MVA, targeted therapy (HR 0.43 95% CI 0.22-0.86), immunotherapy (HR 0.04 95% CI 0.01-0.3), surgical resection (HR 0.38 95% CI 0.18-0.81), and ECOG performance status (0.23 95% CI 0.1-0.54) were associated with improved OS. No specific genetic aberration, RT modality, or number of BM was associated with OS. Conclusions: In pts with BM from NS-NSCLC, the most common molecular aberrations include TP53, EGFR, and KRAS mutations. Treatment with brain RT and modern systemic therapies yields a median survival greater than ten months. The use of targeted therapy or immunotherapy was associated with increased OS.

Renal cell carcinoma (RCC) primary tumor shrinkage on vascular endothelial growth factor (VEGF)-targeted therapy (TT): A pooled analysis.

2018 ◽  
Vol 36 (6_suppl) ◽  
pp. 629-629
Author(s):  
Dominick Bosse ◽  
Xun Lin ◽  
Ronit Simantov ◽  
Aly-Khan A. Lalani ◽  
Ithaar Derweesh ◽  
...  
Keyword(s):  
Liver Metastases ◽  
Primary Tumor ◽  
Cox Regression ◽  
Performance Status ◽  
Objective Response ◽  
Pooled Analysis ◽  
Interferon Α ◽  
Tumor Shrinkage ◽  
Primary Tumors ◽  
Poor Risk

629 Background: Cytoreductive nephrectomy (CRN) is an important treatment modality in patients (pts) with advanced RCC, however the role and timing in the context of VEGF-TT remains under investigation. The aim of this study is to determine the efficacy of VEGF-TT to induce primary tumor shrinkage in advanced RCC. Methods: We conducted a pooled analysis of 12 Pfizer-sponsored trials in pts with metastatic RCC treated with sunitinib, sorafenib, axitinib, bevacizumab, termsirolimus or interferon-α. Primary endpoint was the primary tumor objective response rate (ORR) by RECIST in pts who have not undergone prior nephrectomy. Kaplan-Meier method was used to estimate median overall survival (OS) of responders (PR or CR) v. non-responders. Cox regression adjusting for demographics, histology type, prior therapy, metastasis sites, IMDC risk factors and neutrophil-to-lymphocyte ratio was used to compare OS between pts with and without primary tumor ORR. Results: 565 (12%) out of 4736 pts included had their primary tumors intact, of which 360 (8%) received VEGF-TT. In pts with primary tumor intact, 87% had clear-cell RCC and IMDC risk group were 4% favourable, 33% intermediate, 39% poor, 24% unknown. 35% had bone metastasis and 32% had liver metastases. 65% had ECOG performance status ≥1. Compared to pts with prior nephrectomy, primary tumor intact pts were more likely to have bone or liver metastases or to be IMDC poor risk. Primary tumor ORR was 17% (95% exact CI, 14, 20) in all pts, 19% (95% exact CI, 16, 23) in first line treated pts and 23% (95% Exact CI, 19, 28) in pts treated with VEGF-TT (any line). Primary tumor ORR was 20% (95% exact CI, 15, 26) in IMDC intermediate risk pts and 9% (95% exact CI, 5 – 13) in the poor risk. No pts had PD as best response in their primary tumor at the time they stopped systemic therapy. Median OS was 33.98 months in pts with primary tumor ORR and 9.8 months in pts without ORR, adjusted HR 0.42 [95%CI, 0.28, 0.6; p < 0.0001]. Conclusions: VEGF-TT resulted in primary tumor shrinkage in 23% of pts with IMDC intermediate and poor risk advanced RCC who have not undergone CRN. VEGF-TT may potentially facilitate future CRN in select pts. Trials assessing the utility of CRN are underway.

Oncology precision medicine for hepatobiliary and pancreatic cancer: An institutional review.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e14626-e14626
Author(s):  
Geoffrey Bellini ◽  
Jennifer Jo Godden ◽  
James L. Weese ◽  
Aaron Chevinsky ◽  
Wesley Allan Papenfuss ◽  
...  
Keyword(s):  
Precision Medicine ◽  
Genetic Alterations ◽  
Molecular Testing ◽  
Cancer Type ◽  
Extrahepatic Cholangiocarcinoma ◽  
Term Outcome ◽  
Primary Tumors ◽  
Long Term Outcome ◽  
Molecular Alterations ◽  
Number Of Patients

e14626 Background: Hepatobiliary cancers - hepatocellular carcinoma (HCC), intra or extrahepatic cholangiocarcinoma (I/EC), and gallbladder carcinoma (GB) - and pancreatic adenocarcinoma (PC) remain a leading cause of death with little improvement in long-term outcome. Recent studies have suggested that these cancers harbor actionable mutations to varying degrees. The aim of our study was to examine the number of patients (Pts) with these primary tumors who underwent molecular testing in a large vertically integrated health system. Subsequently, we analyzed the percentage of that population who may be candidates for oncology precision medicine (OPM) directed therapy. Methods: We identified Pts with HCC, IC, EC, GB in an IRB reviewed OPM database of our system over a one year period. Pts who underwent molecular panel testing were selected out, and their molecular alterations were identified and stratified by cancer type. Results: 304 total Pts were identified. 61 (20%) underwent molecular testing broken down as follows: 17/132 (13%) I/EC and HCC, 3/11 (27%) GB, and 41/161 (25%) PC. Quantity not sufficient for testing was in 10/61 (16%), of which 5/10 (50%) were resubmitted and tested successfully. 6/61 (10%) were cancelled or deemed not appropriate. Test recommended potential actionability was 8/17 (47%) of I/EC and HCC, 2/3 (67%) of GB, and 25/41 (61%) of PC. Conclusions: OPM is a dynamic area of increasing testing and learning. We found 13-27% of hepatobiliary and pancreatic Pts had molecular testing, which suggests the potential to increase molecular screening for this difficult group of tumors. Total genetic alterations (TGA) and clinically relevant genomic alterations (CRGA) per patient are similar to Ross et al. ( http://ow.ly/k52a30nBMnU ) for GB. Final interpretation regarding pragmatic actionability (patient on drug) and clinical outcomes are still under investigation.[Table: see text]

scholarly journals Concordance ofKRAS/BRAFMutation Status in Metastatic Colorectal Cancer before and after Anti-EGFR Therapy

2009 ◽  
Vol 2009 ◽  
pp. 1-9 ◽  
Author(s):  
S. Gattenlöhner ◽  
B. Etschmann ◽  
V. Kunzmann ◽  
A. Thalheimer ◽  
M. Hack ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Targeted Therapy ◽  
Metastatic Colorectal Cancer ◽  
Kinase Inhibitors ◽  
Standard Procedure ◽  
Poor Response ◽  
Genetic Alterations ◽  
Primary Tumors ◽  
Mutation Status ◽  
Before And After

Anti-EGFR targeted therapy is a potent strategy in the treatment of metastatic colorectal cancer (mCRC) but activating mutations in theKRASgene are associated with poor response to this treatment. Therefore,KRASmutation analysis is employed in the selection of patients for EGFR-targeted therapy and various studies have shown a high concordance between the mutation status in primary CRC and corresponding metastases. However, although development of therapy related resistance occurs also in the context of novel drugs such as tyrosine kinase-inhibitors the effect of the anti-EGFR treatment on theKRAS/BRAFmutation status itself in recurrent mCRC has not yet been clarified. Therefore, we analyzed 21 mCRCs before/after anti-EGFR therapy and found a pre-/posttherapeutic concordance of theKRAS/BRAFmutation status in 20 of the 21 cases examined. In the one discordant case, further analyses revealed that a tumor mosaicism or multiple primary tumors were present, indicating that anti-EGFR therapy has no influence onKRAS/BRAFmutation status in mCRC. Moreover, as the preselection of patients with aKRASwtgenotype for anti-EGFR therapy has become a standard procedure, sample sets such ours might be the basis for future studies addressing the identification of potential anti-EGFR therapy induced genetic alterations apart fromKRAS/BRAFmutations.

Interstitial high dose rate brachytherapy and cervical dissection the management of recurrent head and neck cancers

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 15529-15529
Author(s):  
A. C. Pellizzon ◽  
P. Novaes ◽  
J. Salvajoli ◽  
R. Fogaroli ◽  
M. Maia ◽  
...  
Keyword(s):  
Dose Rate ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
High Dose Rate ◽  
Local Control Rate ◽  
High Dose ◽  
High Dose Rate Brachytherapy ◽  
Primary Tumors ◽  
Recurrent Cervical Cancer ◽  
Number Of Patients

15529 Background: The literature is scarce regarding the use of interstitial high dose rate brachytherapy (I-HDR) in this setting, most reports are focused on primary tumors. We performed a retrospective analysis of a single institutional polity of treatment using salvage surgery associated to I-HDR at the Radiation Oncology Departments, Hospital do Cancer A.C. Camargo, São Paulo, Brazil. Methods: All patients with recurrent cervical cancer treated with combination of surgery and I-HDR, with or without the addition a new second course of EBRT, biopsy proven squamous cell carcinoma (SCC), Karnofsky performance status up to 60 and, no evidence of distant metastasis. Patients treated from October, 1994 to June, 2004, were retrospectively selected. Results: Twenty-one patients with median age of 53.5 years (range 31–73) were included in the study. The ratio male to female was 3.2:1 and the follow up time ranged from 6 months to 82 months (median - 36 months). Thirteen (61.9%) had a previous course of irradiation, in whom the median total I-HDR dose was 25.8 Gy, inferior when compared to the median dose of 40.7 Gy given to patients without a previous course of EBRT (p = 0.011), but with no influence in OS (p = 0.9436). The only predictive factor for an improved LFRS and OS was margin status, p = 0.0007 and p = 0.0002, respectively Conclusions: Recurrent HNC should have aggressive salvage procedures as they they are life threatening. Although the number of patients is small, our preliminary results are inspiring, leading to a relative high local control rate with acceptable morbidity, No significant financial relationships to disclose.

Phase II Study of Pentosan Polysulfate (PPS) in Patients with AIDS-related Kaposi's Sarcoma

1996 ◽  
Vol 82 (4) ◽  
pp. 360-363 ◽  
Author(s):  
Gilberto Schwartsmann ◽  
Eduardo Sprinz ◽  
Luciane Kalakun ◽  
Nise Yamagushi ◽  
Ernesto Sander ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Phase Ii ◽  
Kaposi's Sarcoma ◽  
Performance Status ◽  
Objective Response ◽  
Kaposi’S Sarcoma ◽  
Phase Ii Clinical Trial ◽  
Low Grade ◽  
Prior Therapy ◽  
Number Of Patients

Aims and background To evaluate the response rate, toxicity and survival of patients with AIDS-related Kaposi's sarcoma (AIDS-KS) treated in a phase II clinical trial of pentosan polysulpate (PPS), an inhibitor of basic-fibroblast growth factor (b-FGF) which blocks the growth of Kaposi's sarcoma cells both in culture and in animal models. Patients and methods Between March 1992 and March 1994 16 homosexual males with histopathologically confirmed AIDS-KS were accrued for this phase II clinical trial. PPS was administered at the dose of 25 mg/m2 q6 hrs at day 1, followed by 25 mg/m2 q12 hrs daily by a subcutaneous injection. The number of patients to be included in the trial was calculated according to the two-stage Gehan method. Toxicity was graded according to the NCI Common Toxicity Criteria, while responses were evaluated according to the WHO Criteria adapted for KS lesions. Patients were all homosexual males, median age 35 (27-43) years, performance status (WHO) 1 (0-2), NYU stage II-IV and prior therapy included vincristine and etoposide (3 cases), local irradiation (4 cases) and meges-trol acetate (2 cases). Concomitant AZT (zidovudine) was given to 3 patients, while DDI (dideoxyinosine) was administered in one case. Results A median of 5 (3-11) weeks of therapy was administered to the patients. Pain at the injection site and low grade fever were the only toxicities observed. Drug-related effects on coagulation parameters or thrombocytopenia were not observed in the trial. One objective response (6%) was documented, which lasted for 9 weeks, while stable disease was observed in three patients, lasting for 11, 9 and 5 weeks, respectively. Conclusion This is the first observation of objective antitumor activity with a b-FGF inhibitor in patients with AIDS-KS. Considering its novelty and the lack of significant toxicity, the authors suggest that this experimental approach deserves further evaluation.

Multi-institutional experience using 5-fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX) in patients with pancreatic cancer (PCA).

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e14519-e14519 ◽  
Author(s):  
Priscila Hermont Goncalves ◽  
Joshua Michael Ruch ◽  
Jennifer Byer ◽  
Anthony Frank Shields ◽  
Minsig Choi ◽  
...  
Keyword(s):  
Performance Status ◽  
Single Agent ◽  
Objective Response ◽  
Treatment Discontinuation ◽  
Phase Iii ◽  
Cancer Center ◽  
Modest Improvement ◽  
Primary Tumors ◽  
Institutional Experience ◽  
Grade 3

e14519 Background: FOLFIRINOX resulted in significant improvement in survival in a recent phase III trial. However, the toxicity associated with its use may be significant. Theobjectives of this study were to determine the tolerability and outcome in patients with advanced PCA treated with FOLFIRINOX in 3 cancer centers in the USA. Methods: This was a retrospective analysis in pts with PCA treated with FOLFIRINOX at Karmanos Cancer Center (Detroit, MI), University of Michigan (Ann Arbor, MI) and Moffitt Cancer Center (Tampa, FL) from 2010 to 2012. Results: 54 patients with advanced PCA (61%males, median age 57.5 years [range 34-73], 72 % Caucasians) were evaluable. 67% of the primary tumors were in the head of the pancreas and 48% of patients had biliary stents prior to treatment. ECOG performance status (PS) was 0-1 in 91%. 91% of the patients had stage IV disease mostly with liver metastases. The median number of cycles received per patient was 5 (1-24). At the outset of treatment, bolus 5FU was omitted in 15% of pts and granulocyte growth factor was given in 89% of the cases. 80% of patients experienced at least one grade 1 or 2 toxicity (fatigue in 44%). Grade 3 toxicities occurred in 26 (48%) pts (fatigue [9]; neutropenia [7]; vomiting [7]; diarrhea [5]; neuropathy [4]; anemia [4]; thrombocytopenia [2] and infection [2]). 13% of patients (7) experienced grade 4 toxicities (vomiting [3]; febrile neutropenia [2] and neutropenia [2]). There was no grade 5 toxicity. Dose reduction was necessary in 87% of pts. 17% of pts required hospitalization during treatment. Partial responses were documented in 39% and stable disease in 29%. Side effects were the reason for treatment discontinuation in 35% of this population. Median PFS and OS were 3.8 (0.9 – 13.6) and 7.2 (0.5 – 17.8) months, respectively. Conclusions: In this multi-institutional experience in pts with PCA, significant grade 3 and 4 toxicities were associated with the FOLFIRINOX regimen leading to treatment discontinuation in a third of the population. PFS and OS represented a modest improvement over what would be expected from using single agent gemcitabine despite the relatively high objective response rate.

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