Nab-paclitaxel/S-1(AS) versus nab-paclitaxel/gemcitabine(AG) for first-line chemotherapy in advanced pancreatic ductal adenocarcinoma (aPDAC): A retrospective analysis of efficacy and safety.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e15743-e15743 ◽  
Author(s):  
Yuan Zong ◽  
Zhi Peng ◽  
Ming Lu ◽  
Xicheng Wang ◽  
Jun Zhou ◽  
...  
Keyword(s):  
Locally Advanced ◽  
Primary Lesion ◽  
Ductal Adenocarcinoma ◽  
Rank Test ◽  
Efficacy And Safety ◽  
Phase Ii Trials ◽  
First Line ◽  
Intention To Treat ◽  
Grade 3 ◽  
Line Chemotherapy

e15743 Background: AG significantly improved PFS and OS compared with gemcitabine monotherapy in patients (pts) with metastatic PDAC, but the confirmed ORR was limited to 23% with increased grade 3 or 4 myelosuppression. In GEST and JASPAC01 studies, S-1 showed non-inferior or superior activity to gemcitabine in advanced and postoperative PDAC. S-1 also developed less hematologic adverse events especially in neutropenia and was a convenient oral alternative. Two single-arm phase II trials in China demonstrated high ORR of 50.0-53.1% with AS. We investigated the efficacy and safety of first-line chemotherapy with AS versus AG in pts with aPDAC. Methods: A retrospective review was conducted of aPDAC pts treated with first-line AS and AG in GI dpt. Of PUCH between 11/2013 and 12/2018. Pts received 125mg/m2 nab-paclitaxel intravenously (IV) on day1, and 80-100mg S-1 orally per day on day1-7 every two weeks in AS cohort, while pts received 125mg/m2 nab-paclitaxel IV on day1,8, and 1000mg/m2 gemcitabine IV on day1,8 every three weeks in AG cohort. ORR, ORR of primary lesion, DCR, PFS, OS and safety were analysed between two cohorts. Survival outcomes were evaluated by Kaplan-Meier method and compared with the log-rank test. A Cox proportional hazard model was made to determine independent predictors of survival. Results: A total of 70 pts (45 in AS cohort, 25 in AG cohort) with locally advanced (4%) and metastatic (96%) PDACs were identified. 75% were male and the median age was 65(range 36-72). Among intention-to-treat population, the ORR and DCR were 40.0% vs 32.0% (p = 0.70) and 75.6% vs 64.0% (p = 0.57) in AS and AG cohort, respectively. The ORR of primary lesion was 31.1% with AS vs 20.0% with AG (p = 0.73). With the median follow-up of 9.8 months(range 2.3-22.2), the median PFS and OS were 4.7m vs 6.7m (HR, 1.2; 95% CI, 0.6 to 2.4; p = 0.62) and 10.3m vs 11.3m (HR, 0.9; 95% CI, 0.5 to 1.8; p = 0.78) in AS and AG cohort, respectively. Grade 3/4 toxicities occurred in 31.1% AS vs 36.0% AG (p = 0.59). Most G3/4 toxicities were: leukopenia/neutropenia (26.7% vs 20.0%), febrile neutropenia (2.2% vs 8.0%), thrombocytopenia (0 vs 12%), fatigue (4.4% vs 12%), peripheral neuropathy (0 vs 8.0%). In multivariate analysis, liver metastasis was the only independent predictor of poor OS (HR 0.3, 95%CI 0.1-0.8, p = 0.014). Conclusions: AS was a comparable and convenient alternative with manageable toxicities in aPDAC. There was a trend towards improved ORR of primary lesion compared with AG.

scholarly journals A Phase II Study of Docetaxel and Epirubicin in Advanced Adult Soft Tissue Sarcomas (STS)

Sarcoma ◽  
2004 ◽  
Vol 8 (4) ◽  
pp. 129-133 ◽  
Author(s):  
Haralabos P. Kalofonos ◽  
Charalabos Kourousis ◽  
Michalis V. Karamouzis ◽  
Gregoris Iconomou ◽  
Ekaterini Tsiata ◽  
...  
Keyword(s):  
Response Rate ◽  
Phase Ii Study ◽  
Locally Advanced ◽  
Soft Tissue Sarcomas ◽  
Complete Response ◽  
Efficacy And Safety ◽  
First Line ◽  
Grade 3 ◽  
Epirubicin Combination ◽  
Line Chemotherapy

Purpose:The aim of this study was to determine the efficacy and safety of docetaxel plus epirubicin combination as first-line chemotherapy in patients with locally advanced and/or metastatic adult STS.Patients and Methods:Eighteen patients were treated with epirubicin 30 mg/m2on days 1 to 3 and docetaxel 100 mg/m2on day 1 every 3 weeks.Results:Fifteen out of 18 patients (83.4%) were assessable for response. No complete response was recorded. Three (20%) patients achieved PR, 3 had SD and 9 PD. The overall median survival was 14 months (range, 3–48 months) and the median time to disease progression was 4 months (range, 2–45 months). Grade ≥ 3 neutropenia occurred in 88% and neutropenic fever in 27.8% of patients. Other toxicities were mild. No treatment related deaths occurred.Discussion:Docetaxel plus epirubicin combination achieved low response rate with severe myelotoxicity in patients with advanced STS.

Efficacy and safety of dose-dense modified TCF regimen (TCF-dd) in metastatic or locally advanced gastroesophageal cancer (GEC).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 4112-4112
Author(s):  
Laura Toppo ◽  
Gianluca Tomasello ◽  
Wanda Liguigli ◽  
Margherita Ratti ◽  
Rossana Poli ◽  
...  
Keyword(s):  
Dose Reduction ◽  
Locally Advanced ◽  
Efficacy And Safety ◽  
Intention To Treat ◽  
Adequate Organ Function ◽  
Grade 3 ◽  
Dose Dense ◽  
Metastatic Sites ◽  
Chemotherapy Efficacy

4112 Background: TCF is a standard first line option for GEC. The Norton-Simon hypothesis suggests that chemotherapy efficacy can be enhanced by decreasing intervals between cycles. We previously reported on the high activity of TCF-dd in GEC (Tomasello 2010). The aim of this study is to investigate the efficacy and safety of this intensified dose-dense regimen in a single-center large cohort of patients (pts). Methods: 150 pts with measurable or evaluable GEC, PS 0-2, with adequate organ function, treated in our center from 2004 to 2012 received TCF-dd: Docetaxel (60-85 mg/m2 d 1), Cisplatin (50-75 mg/m2 d 1), l-Folinic Acid (100 mg/m2 d 1-2), 5-FU (400 mg/m2 bolus d 1-2, and 600 mg/m2 as a 22 h continuous infusion d 1-2), plus Pegfilgrastim 6 mg d 3, every 14 days. Pts aged ≥ 65 years received the same schedule with a dose reduction by 30%. Analysis was based on the intention to treat population. Results: At a median follow-up of 44 months, 128 pts were evaluable for response, all for survival. Median age 65 (range 31-81), M:F 112:38. 17 pts (11%) with locally advanced inoperable GEC, 133 pts (89%) with metastatic GEC. Metastatic sites: liver 40%, peritoneum 31%, bone 14%, lung 12%. A median of 4 cycles (range 1-7) per patient was administered. 33% required a dose reduction. 33% were treated without any delay. 10 CR, 74 PR, 24 SD and 20 PD were observed, for an ORR of 66% (95% CI 57-74). Median OS was 13 months (95% CI 9.7-14.2). Most frequent grade 3/4 toxicities: neutropenia (34%), asthenia (28%), thrombocytopenia (17%), hypokalemia (16%), diarrhea (11%), febrile neutropenia (10%), anemia (9%), and stomatitis (4%). 11 pts (7%) [7 metastatic, 4 locally advanced] became operable after TCF-dd and underwent surgery. We identified 12 metastatic pts (8%) with overall survival > 3 years and 7 (5%) still maintaining a long lasting CR at the time of the current analysis. Conclusions: TCF-dd in GEC is very active and may be an option for conversion therapy. Toxicity can be relevant and requires a careful monitoring.

scholarly journals Modified FOLFIRINOX versus gemcitabine plus oxaliplatin as first-line chemotherapy for patients with locally advanced or metastatic cholangiocarcinoma: a retrospective comparative study

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Lu Zou ◽  
Xuechuan Li ◽  
Xiangsong Wu ◽  
Jiujie Cui ◽  
Xuya Cui ◽  
...  
Keyword(s):  
Locally Advanced ◽  
Group Versus ◽  
Progression Free Survival ◽  
Severe Toxicity ◽  
First Line ◽  
School Of Medicine ◽  
Grade 3 ◽  
Retrospective Comparative Study ◽  
Registration Date ◽  
Line Chemotherapy

Abstract Background Gemcitabine plus platinum as the first-line chemotherapy for cholangiocarcinoma (CCA) has limited efficacy. The aim of this study was to evaluate the effectiveness of modified FOLFIRINOX (mFOLFIRINOX) compared to that of gemcitabine plus oxaliplatin (Gemox) for patients with locally advanced or metastatic CCA. Methods From January 2016 to December 2019, consecutive patients who were diagnosed with locally advanced or metastatic CCA were treated with either mFOLFIRINOX or Gemox as a first-line chemotherapy. The main endpoint was Progression free survival (PFS). The second endpoints were Overall survival (OS), Disease control rate (DCR) and incidence of severe toxicity (grade 3–4). Tumors were evaluated at baseline and thence every 4–6 weeks. The study was designed and carried out in accordance with the principles of the declaration of Helsinki, approved by the Ethics Committee of Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine (XHEC-D-2020-154) and registered with ClinicalTrials.gov, number NCT04305288 (registration date: 12/03/2020). Results Of 49 patients in this study, 27 were in the FOLFIRINOX regimen group and 22 in the Gemox regimen group. There were no significant differences between groups in baseline characteristics. The DCR was 77.8% in the mFOLFIRINOX group and 63.5% in the Gemox group. The corresponding median PFS was 9.9 months (95% confidence interval [CI], 7.3–12.4) in the mFOLFIRINOX group versus 6.4 months (95% CI,3.6–9.2, p = 0.040) in the Gemox group. The corresponding median OS was 15.7 months (95% CI, 12.5–19.0) versus 12.0 months (95% CI, 9.3–14.8, p = 0.099). Significantly more grade 3–4 vomiting occurred in the mFOLFIRINOX than the Gemox groups (7 (25.9%) vs 1 (4.5%), p = 0.044). Conclusions First-line mFOLFIRINOX offered more promising results in patients with advanced or metastatic CCA.

scholarly journals Efficacy and safety of bevacizumab in combination with oxaliplatin, irinotecan and fluoropyrimidine-based therapy in advanced colorectal cancer

2007 ◽  
Vol 15 (1-2) ◽  
pp. 10-14 ◽  
Author(s):  
Ivan Popov ◽  
Dino Tarabar ◽  
Dusan Jovanovic ◽  
Vladimir Kovcin ◽  
Stojan Radic ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Clinical Benefit ◽  
Advanced Colorectal Cancer ◽  
Median Number ◽  
Second Line ◽  
Efficacy And Safety ◽  
First Line ◽  
Intention To Treat ◽  
Grade 3 ◽  
The Moment

Background: Bevacizumab is an anti-VEGF, humanized mAb that is the most advanced agent of its class in clinical development. Several studies have examined bevacizumab in combination with chemotherapy in the first- and second-line settings in patients with metastatic CRC. Despite of that, there is lack of information concerning the extent to which bevacizumab can be used to treat metastatic CRC. We still need more evidence related to efficacy and safety of bevacizumab in different settings, or sequential treatments. The aim of this study was to investigate efficacy and safety of bevacizumab added to different chemotherapy in patients with metastatic CRC. Methods: This was a controlled, prospective, multicentre, cohort study. Thirty patients with advanced colorectal cancer were enrolled into this study. Bevacizumab was applied with oxaliplatin-, irinotecan-, 5FU- or capecitabine -based chemotherapy in the first-, second- or third-therapy lines. Totally 261 cycles were applied. The median number of applied cycles per patient was 8 (range 2-16). Results: Objective tumor response (RR) was seen in 11 patients 37% (95%CI 19-69%) calculated on an intention-to-treat basis. The median duration of response was 12 months. Three of 11 patients (27%) with PR had secondary surgery. RR was seen in 9 of 16 patients (56%) who received bevacizumab in the first-line treatment and in 2 of 14 patients (14%) who received therapy in the second+ lines (p=0.02). Clinical benefit (PR+SD) was seen in 22 (74%) patients. 75% of patients achieved clinical benefit in the first-line and 74% in the second+ chemotherapy lines. The median time to progression (TTP) of the patients is was 9 + months (95%CI 7 - + ?) at the moment of this analysis. The median TTP of patients who received bevacizumab in the first line was 11 months (95%CI 8 - + ?). The median TTP of patients who received bevacizumab in the second+ lines was 5.5 months (95%CI 4 - + ?) (p=0.015). The median survival time (OS) for all patients was 9 + months (95%CI 7 - + ?). The median OS at the moment of analysis was 11 months (95%CI 9 - + ?) for patients receiving bevacizumab in the first line, and 7 months for patients receiving the drug in the second+ lines (95%CI 6 - + ?) (p=0.024). The incidence of any toxicity grade 3-4 was less than 10%. Bevacizumab associated incidence of grade 3-4 side effects did not exceed 5%. Hypertension 5% and thromboembolism 5% were the most frequent events. Gastrointestinal perforation did not occur. There was one toxic death due to sepsis and not directly associated with bevacizumab toxicity. Conclusion: Bevacizumab can safely be added to different chemotherapeutic regimens in first- and second+ line. The conferred benefit in overall survival, TTP and response rate obviously requires randomized trials.

scholarly journals Avelumab first-line maintenance plus best supportive care (BSC) vs BSC alone for advanced urothelial carcinoma: JAVELIN Bladder 100 Japanese subgroup analysis

2022 ◽  
Author(s):  
Yoshihiko Tomita ◽  
Yoshiaki Yamamoto ◽  
Norihiko Tsuchiya ◽  
Hiroomi Kanayama ◽  
Masatoshi Eto ◽  
...  
Keyword(s):  
Supportive Care ◽  
Urothelial Carcinoma ◽  
Locally Advanced ◽  
Progression Free Survival ◽  
Japanese Patients ◽  
Best Supportive Care ◽  
Efficacy And Safety ◽  
First Line ◽  
Advanced Urothelial Carcinoma ◽  
Grade 3

Abstract Background The phase 3 JAVELIN Bladder 100 trial showed significantly prolonged overall survival (OS) with avelumab as first-line (1L) maintenance therapy + best supportive care (BSC) vs BSC alone in patients with advanced urothelial carcinoma (UC) that had not progressed with 1L platinum-containing chemotherapy. Efficacy and safety were assessed in patients enrolled in Japan. Methods Patients with locally advanced or metastatic UC that had not progressed with 4–6 cycles of 1L platinum-containing chemotherapy were randomized to avelumab (10 mg/kg intravenously every 2 weeks) + BSC or BSC alone. The primary endpoint was OS, and secondary endpoints included progression-free survival (PFS) and safety. Results In Japanese patients (n = 73) randomized to avelumab + BSC (n = 36) or BSC alone (n = 37), median OS was 24.7 months (95% CI, 18.2-not estimable) vs 18.7 months (95% CI, 12.8–33.0), respectively (HR, 0.81 [95% CI, 0.41–1.58]), and median PFS was 5.6 months (95% CI, 1.9–9.4) vs 1.9 months (95% CI, 1.9–3.8), respectively (HR, 0.63 [95% CI, 0.36–1.11]). In the avelumab + BSC and BSC-alone arms, grade ≥ 3 treatment-emergent adverse events (AEs) occurred in 50.0% vs 8.1%, including grade ≥ 3 treatment-related AEs in 13.9% vs 0%, respectively. Efficacy and safety results in Japanese patients were generally consistent with findings in the overall trial population. Conclusion Avelumab 1L maintenance treatment showed a favorable benefit-risk balance in Japanese patients, supporting avelumab 1L maintenance as a new standard of care in Japanese patients with advanced UC that has not progressed with 1L platinum-containing chemotherapy. Trial registration Clinicaltrials.gov NCT02603432.

MO19390 (SAiL): Incidence and management of hypertension (HTN) during bevacizumab (Bv)-based first-line therapy in patients (pts) with advanced non-small cell lung cancer (NSCLC)

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e19002-e19002
Author(s):  
P. Garrido Lopez ◽  
J. Laskin ◽  
G. Jiang ◽  
F. Barlesi ◽  
D. Isla ◽  
...  
Keyword(s):  
Locally Advanced ◽  
Age Groups ◽  
Channel Blockers ◽  
Angiotensin Ii Receptor ◽  
First Line ◽  
Open Label ◽  
Antihypertensive Medications ◽  
Serious Adverse Events ◽  
Grade 3 ◽  
Line Chemotherapy

e19002 Background: SAiL is an ongoing, multicenter, international, open-label trial investigating the safety and efficacy of first-line Bv in combination with a range of standard first-line chemotherapy regimens in >2,000 pts with advanced NSCLC. Methods: Eligible pts had locally advanced, metastatic or recurrent non-squamous NSCLC. Pts received Bv (7.5mg/kg or 15mg/kg q3w) with standard first-line chemotherapy for up to 6 cycles, then Bv monotherapy until disease progression. Pts with uncontrolled HTN (systolic >150mmHg and/or diastolic >100mmHg) or active cardiovascular disease at baseline were excluded. The primary endpoint was the incidence of serious adverse events (SAEs) related to Bv, and AEs of special interest, including hypertension. Bv was interrupted for persistent or symptomatic grade 3 HTN and discontinued if blood pressure remained uncontrolled by medication. Bv was discontinued for grade 4 hypertension. Results: This analysis was based on 2,008 pts who received at least 1 dose of study medication (data cut-off July 2008): median age was 59 and ECOG PS 0/1/2 (%) was 38.1/56.1/5.8. Antihypertensive medications at baseline included ACE inhibitors (11.3%), Angiotensin II receptor blockers (6.2%), beta-blockers (10.9%), calcium channel blockers (7.7%) and diuretics (8%). Pts received a median of 5 Bv cycles and 4 chemotherapy cycles. Overall, 388 patients (19.3%) had a total of 487 incidents of HTN (any grade), occurring equally in patients ≤65 and >65 years of age (18.9% and 20.2%, respectively). Only six pts (0.3%) had grade ≥3 HTN events related to Bv meeting the criteria for SAE. The overall incidence of HTN was consistent across the various types of chemotherapy regimens. Conclusions: The incidence of grade ≥3 HTN was low, and the overall HTN incidence was similar across age groups and chemotherapy regimens. Updated results will be presented, including data on HTN management and evolution of HTN events during administration of antihypertensive medication. [Table: see text]

FOLFIRI regimen as second-/third-line chemotherapy in patients with advanced pancreatic adenocarcinoma refractory to gemcitabine and platinum salts: A retrospective series of 70 patients.

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 272-272
Author(s):  
C. Neuzillet ◽  
O. Hentic ◽  
B. Rousseau ◽  
V. Rebours ◽  
L. Bengrine-Lefèvre ◽  
...  
Keyword(s):  
Pancreatic Adenocarcinoma ◽  
Locally Advanced ◽  
Advanced Pancreatic Cancer ◽  
Progression Free Survival ◽  
Tumor Control ◽  
First Line ◽  
Dose Adaptation ◽  
Grade 3 ◽  
Advanced Pancreatic Adenocarcinoma ◽  
Line Chemotherapy

272 Background: Gemcitabine-based regimen is a standard of first-line chemotherapy in patients with advanced pancreatic adenocarcinoma (PAC) and 5-FU/oxaliplatin combination is an option for second line (Oettle, 2009). Some data suggest a potential efficacy of 5-FU/irinotecan regimen (FOLFIRI) as first-line treatment (Taïeb, 2007)or in patients with gemcitabine/platinum-refractory advanced PAC (Yoo, 2009; Gebbia, 2010). Methods: All consecutive patients with unresectable advanced PAC (01-2005/05-2010) and OMS≤2 received FOLFIRI-1 (irinotecan 180 mg/m2 D1, n=60) or FOLFIRI-3 regimen (irinotecan 100 mg/m2 D1/D3 n=10) after failure of gemcitabine- and platinum-based chemotherapies as a systematic policy in two institutions. Following data were analyzed: tumor response, progression free survival (PFS), overall survival rate (OS), and grade 3-4 toxicities. Results: Seventy patients were studied. Median age was 60 years (range: 24-81); 37 (52.9%) were male; 30 (42.9%) were PS 0, 27 were PS 1 and 13 were PS 2. Cancer was locally advanced in 15.7% and metastatic in 84.3% of patients. Before FOLFIRI regimen, patients received 1 line (n=24, 34.3%), 2 lines (n=40, 57.1%) or ≥ 3 lines (n=6, 8.8%) chemotherapy. PFS with previous line was less than 3 months in most patients. Tumor control was achieved in 31 (44.3%) patients (partial response: 5, stable disease: 26). PFS was 17% at 12 months and 3% at 24 months. Median PFS was 23 weeks (range: 2-147). OS was 24% at 12 months and 9% at 24 months. Median OS was 24 weeks (range: 2-147). From the initial diagnosis, 1-year and 2-year survivals were 79% and 32%. Dose adaptation was required in 21 (30.0%) patients. Eighteen (25.7%) patients had grade 3-4 toxicities, mainly hematologic (n=13) or digestive (n=6). Febrile neutropenia occurred in 3 patients without death. Conclusions: FOLFIRI regimen after failure of gemcitabine- and platinum-based regimens for advanced PAC in our study had an acceptable toxicity and a surprising efficacy in patients OMS 0-2. These results suggest that FOLFIRI regimen should be further tested as first-line chemotherapy in patients with advanced pancreatic cancer. No significant financial relationships to disclose.

Efficacy and safety of nab-paclitaxel plus S-1(nab-P/S-1) versus nab-paclitaxel plus gemcitabine (nab-P/Gem) for first-line chemotherapy in advanced pancreatic ductal adenocarcinoma (aPDAC): A randomized study.

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 717-717 ◽  
Author(s):  
Yuan Zong ◽  
Zhi Peng ◽  
Xicheng Wang ◽  
Lin Shen ◽  
Jun Zhou
Keyword(s):  
Phase Ii ◽  
Randomized Study ◽  
Locally Advanced ◽  
Primary Lesion ◽  
Ductal Adenocarcinoma ◽  
Hematologic Toxicity ◽  
Phase Ii Trials ◽  
Duration Of Treatment ◽  
Significant Difference

717 Background: Nab-P/Gem significantly improved survival compared with gem in patients (pts) with metastatic PDAC, but the ORR was limited to 23% with increased myelosuppression. Two phase II trials demonstrated high ORR of 50.0-53.1% with nab-P/S-1 and showed less hematologic toxicity. Methods: A randomized (1:1) phase II trial was conducted. Eligibility required treatment-naïve pts with unresectable PDAC. Pts received nab-P 125mg/m2on day 1 + S-1 80-120mg orally per day on day 1-7 every 2 weeks or nab-P 125mg/m2+ Gem 1000mg/m2 on days 1,8 every 3 weeks. With an increase of ORR from 25% to 50%, 100 pts were required for 90% power at a two-sided significance level of 0.05. We enrolled 40 pts for a pilot study. Primary endpoints were ORR and 6-month PFS rate. Secondary endpoints were ORR of primary lesion, DCR, PFS, OS and safety. Results: 40 pts were enrolled between 06/2018 and 06/2019, including locally advanced (27.5%) and metastatic (72.5%) PDACs. 42.5% were male and the median age was 61 (range, 36-75) years old. The median duration of treatment was 2.3 months in nab-P/S-1 (n = 20) and 2.7 months in nab-P/Gem (n = 20). In the intention-to-treat (ITT) population, the ORR and DCR were 35.0% vs 25.0% ( P= 0.49) and 70.0% vs 70.0%, respectively.The ORR of primary lesion was 30.0% vs 25.0% ( P= 0.72). In the evaluable pts (nab-P/S-1 n = 18, nab-P/Gem n = 18), the ORR, DCR and the ORR of primary lesion were 38.9% vs 27.8%, 77.8% vs 77.8% and 35.3% vs 29.4%, respectively.With the median follow-up of 5.0 (range 0.3-11.4) months, the median PFS and 6-month PFS rate was 6.3 vs 5.7 months and 56.1% vs 36.2%( P= 0.61) for nab-P/S-1 and nab-P/Gem, respectively. The median OS have not reached. Grade 3/4 toxicities occurred in 30.0% nab-P/S-1 and 30.0% nab-P/Gem: leukopenia/neutropenia(15.0% vs 25.0%), febrile neutropenia (0 vs 5.0%), rash (0 vs 5.0%) and diarrhea (10.0% vs 0). Conclusions: Compared with nab-P/Gem, nab-P/S-1 had higher ORR, ORR of primary lesion and longer PFS without significant difference. Nab-P/S-1 developed a trend towards less hematologic toxicity. Follow up for survival is ongoing. Clinical trial information: 03636308.

Combination chemotherapy for pancreatic cancer in older adults: Efficacy and safety analysis of patients at a majority-Hispanic NCI-designated cancer center.

2019 ◽  
Vol 37 (4_suppl) ◽  
pp. 389-389 ◽  
Author(s):  
Emily Henkel ◽  
Brian Hernandez ◽  
Joel Michalek ◽  
Devalingam Mahalingam ◽  
Sukeshi Patel Arora
Keyword(s):  
Older Adults ◽  
Pancreatic Cancer ◽  
Clinical Trials ◽  
Combination Chemotherapy ◽  
Stage Iv ◽  
Rank Test ◽  
Cancer Center ◽  
Efficacy And Safety ◽  
First Line ◽  
Grade 3

389 Background: Pancreatic cancer (PCa) is more frequent in older adults, but older patients are underrepresented in large clinical trials. There is limited data on efficacy and safety of regimens such as FOLFIRINOX or nab-paclitaxel/gemcitabine (nab-gem) in older adults, especially Hispanics. Therefore, we compared the efficacy and safety of first-line PCa regimens in older adults. Methods: Retrospective analysis of stage IV PCa at our Hispanic-majority NCI-designated cancer center from 2000-2017. mPFS and mOS estimated from KM curves and groups were statistically compared with the log-rank test. The magnitude of association between dichotomous factors and survival was estimated with the hazard ratio (HR). Results: Forty-eight pts, mean age 71.7 years, median 69.2 (range 65-90). 31% Hispanic; 50% Male. First-line treatment: FOLFIRINOX (n=9), nab-gem (n=11), gem (n=11), other (n=9), supportive care (n=2). Baseline ECOG 0-1: 100%, 94%, 45%, 100%, 1% (p=0.004). Baseline albumin: 3.4, 3.4, 3.1, 3.5, 2.25 (p=0.06). mOS 7.1 months (95% CI 5.9-10.1). mPFS 5.6 months (95% CI: 5.3-NR). mOS by group: 8.6 mo, 7.1 mo, 3.2 mo, 2.9 mo, not available (p=0.95). Most patients had grade 0-2 toxicities (See table). Grade 3-4: fatigue n=2, neutropenia n=1, neuropathy n=1, mucositis n=1. Conclusions: Combination systemic chemotherapy are tolerated in older adults with PCa; however, in our cohort, survival was lower than historic phase 3 clinical trials with these regimens. Patients receive 2+ drugs had higher ECOG and albumin at baseline. Prospective studies with geriatric assessments are needed to determine patients who benefit from combination chemotherapy. [Table: see text]

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