Clinical outcome of modified FOLFIRINOX versus gemcitabine plus nab-paclitaxel as first line chemotherapy in metastatic pancreatic cancer.

2017 ◽  
Vol 35 (4_suppl) ◽  
pp. 438-438 ◽  
Author(s):  
Kazuo Watanabe ◽  
Yusuke Hashimoto ◽  
Kumiko Umemoto ◽  
Hideaki Takahashi ◽  
Mitsuhito Sasaki ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Febrile Neutropenia ◽  
Adverse Events ◽  
Performance Status ◽  
Objective Response ◽  
Metastatic Pancreatic Cancer ◽  
Cancer Center ◽  
First Line ◽  
Ecog Performance Status ◽  
Line Chemotherapy

438 Background: FOLFIRINOX and Gemcitabine plus nab-paclitaxel (GN) have been established as first line chemotherapy in metastatic pancreatic cancer (mPC). But few data support preferable first line choice of these two regimens in “real-world” clinical setting. Methods: We retrospectively enrolled 135 chemotherapy-naive mPC patients treated with modified FOLFIRINOX (mFFX) or GN at National Cancer Center Hospital East between December 2013 and September 2015. mFFX is a modified regimen of reduced dose of irinotecan 150mg/m2 and eliminated bolus 5-FU from original FFX. GN consists of gemcitabine 1000mg/m2 plus nab-paclitaxel 125mg/m2 day1,8,15 every 4 weeks. We compared characteristics, efficacy and adverse events between mFFX and GN. Results: Seventy patients were treated with mFFX and 65 patients with GN as first line therapy. Demographic and baseline characteristics (mFFX/GN) were similar as follows: ECOG performance status (0-1): 100% / 99%, Gender (male): 66% / 69%, liver metastasis: 56%/49%, peritoneal metastasis: 34% / 31%, prior biliary drainage: 21%/17%, median observation period: 330 / 265 days, respectively. The population of elderly patients ( > 75y) was smaller in mFFX than GN (4.3% vs. 12%, p = 0.05). Objective response rate (27% vs. 39%, p = 0.02) and disease control rate (79% vs. 92%, p = 0.02) were significantly lower in mFFX than in GN. Median OS was 11.5 months (95% CI: 9.7-16.8) in mFFX and 14.0 months (95% CI: 12.2 - not reached) in GN. Median PFS was 5.7 months (95% CI: 3.4-7.1) in mFFX and 6.5 months (95% CI: 6.1-7.9) in GN. One-year survival rate was significantly higher in GN than in mFFX (44% vs. 67%, p = 0.0006). Incidences of grade 3 or 4 neutropenia (47% vs. 45%), diarrhea (1.4% vs. 2.0%), and peripheral neuropathy (4.2% vs. 4.6%) were similar in each group. On the other hand, incidences of febrile neutropenia (8.5% vs. 2.0%, p = 0.06) and G-CSF use rate (21% vs. 0%, p < 0.0001), anorexia (13% vs. 3%, p = 0.03) were significantly higher in mFFX than those of GN. Conclusions: Patients treated with GN showed more favorable efficacy and survival. Incidences of most adverse events did not differ between mFFX and GN,whereas febrile neutropenia occurred more frequently in mFFX.

FOLFIRINOX versus gemcitabine nab-paclitaxel for advanced pancreatic cancer: KU Cancer Center experience.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e15744-e15744 ◽  
Author(s):  
Anup Kasi ◽  
Akshay Middinti ◽  
An Cao ◽  
Pratikkumar Vekaria ◽  
Devangi Patel ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Adverse Events ◽  
Objective Response ◽  
Locally Advanced ◽  
Advanced Pancreatic Cancer ◽  
Pancreatic Head ◽  
Cancer Center ◽  
Disease Rate ◽  
First Line ◽  
Significant Difference

e15744 Background: FOLFIRINOX (FFN) and Gemcitabine plus nab-paclitaxel (GN) have been established as first line chemotherapy in advanced pancreatic cancer (PC). But there is no head-to-head randomized trial data available to support preferable first line choice between these two regimens. Methods: We retrospectively evaluated 154 chemotherapy-naïve locally advanced and metastatic PC patients treated with FFN or GN at KU Cancer Center between January 2011 and November 2016. FFN consisted of Oxaliplatin 85mg/m2, Irinotecan 180mg/m2, 5-FU 400mg/m2 as a bolus and 2,400 mg/m2over 46 hour on days 1 and 15 every 4 weeks. GN consisted of Gemcitabine 1000mg/m2 plus nab-paclitaxel 125mg/m2 day1,8,15 every 4 weeks. We compared characteristics, efficacy and adverse events between FFN and GN. Results: 107 patients were treated with FFN and 47 patients with GN as first line therapy. Demographic and baseline characteristics (FFN/GN) were as follows: Median age 61/63 years, ECOG performance status (0-1): 90% / 83%, Gender (male): 57% / 54%, distant metastases: 52%/70%, biliary stenting: 41%/20%, locally advanced tumor: 48%/30%, pancreatic head tumors: 63%/55%, median number of cycles: 4/4 respectively. Objective response rate (13% vs. 10%), Stable disease rate (76% vs 82%) and disease control rate (89% vs. 92%, p = 0.5) were similar in FFN and in GN. Median PFS was 11.7 months (95% CI: 7.2-16.1) in FFN and 5.7 months (95% CI: 2.7-8.8) in GN [p = 0.07]. Median OS was 15.9 months (95% CI: 13.7-18.1) in FFN and 10.8 months (95% CI: 7.1 – 14.5) in GN [p = 0.17]. Incidences of grade 3 or higher adverse effects were neutropenia (33% vs. 17%), anemia (14% vs 31%), thrombocytopenia (28% vs 6%), elevated creatinine (2.8% vs 4%), elevated transminases (3.7% vs 6%), diarrhea (5% vs. 0%), and peripheral neuropathy (6% vs. 6%) respectively. Conclusions: Patients treated with FFN showed statistically better PFS compared to GN. However this difference in PFS did not translate into statistically significant difference in OS. Response rates were similar. Incidences of adverse events were relatively more with FFN compared to GN as expected.

Randomized multicenter trial of 3 weekly cabazitaxel versus weekly paclitaxel chemotherapy in the first-line treatment of HER2 negative metastatic breast cancer (MBC).

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 1008-1008
Author(s):  
Amit Bahl ◽  
Jeremy Braybrooke ◽  
Alicia Bravo ◽  
Emily Foulstone ◽  
Jessica Ball ◽  
...  
Keyword(s):  
Peripheral Neuropathy ◽  
Adverse Events ◽  
Performance Status ◽  
Objective Response ◽  
Significant Risk ◽  
Weekly Paclitaxel ◽  
First Line ◽  
Patient Reported ◽  
Grade 3 ◽  
Line Chemotherapy

1008 Background: Paclitaxel is commonly used as first line chemotherapy for HER2 negative MBC. However, with response rates of 21.5-53.7% and a significant risk of peripheral neuropathy there is a need for more effective and better tolerated chemotherapy (CCT). Methods: This open label randomised (1:1) phase 2 trial compared 6 cycles of cabazitaxel (25 mg/m2) every 3 weeks, with weekly paclitaxel (80mg/m2) over 18 weeks as first line CCT. HER2 negative and performance status ≤1 patients were eligible. Patients on cabazitaxel received GCSF prophylaxis. Primary endpoint was Progression Free Survival (PFS) with 127 events required to detect a hazard ratio (HR) of 0.65 with 85% power. Secondary endpoints included objective response rate (ORR; RECIST 1.1), time to response (TTR), overall survival (OS), safety and tolerability and quality of life (QoL). Results: 158 patients were recruited from 14 UK hospitals (79 in each arm). Median age (range) was 56(34-81) in the cabazitaxel arm and 61(34-79) in the paclitaxel arm. 61% of patients were performance status 0. Median time on treatment was 15 weeks for both arms, but more patients on paclitaxel had a treatment delay (61% vs 39%) or dose reduction (37% vs 24%). Comparing cabazitaxel to paclitaxel after 146 PFS events, median PFS was 6.7 vs 5.8 months (HR 0.84; 95%CI 0.60–1.18, P = 0.3). There was no difference in OS, median 19.3 vs 20.0 months (HR 0.94; 95%CI 0.63-1.40, P = 0.7), ORR (42% vs 37%) or TTR (HR 1.09; 95%CI 0.68–1.74, P = 0.7). Grade ≥3 adverse events occurred in 42% of patients on cabazitaxel and 48% on paclitaxel. Diarrhoea, febrile neutropenia and nausea were the most common grade ≥3 events in the cabazitaxel arm with rates of 11%, 11% and 10% respectively compared to 1%, 1% and 0% in the paclitaxel arm. In the paclitaxel arm the top grade ≥3 events were lung infection and peripheral neuropathy, 6% and 5% respectively compared to 2.5% and 0% in the cabazitaxel arm. Peripheral neuropathy of any grade was reported by 55% of patients treated with paclitaxel vs 17% on cabazitaxel. Alopecia occurred in 41% of patients on paclitaxel compared to 27% on cabazitaxel. Adverse events leading to discontinuation were more frequent with paclitaxel (22%) than cabazitaxel (14%). Over the course of treatment, mean EQ5D single index utility score (+0.05; 95%CI 0.004-0.09, P = 0.03) and visual analogue scale score (+7.7; 95%CI 3.1-12.3, P = 0.001) were higher in the cabazitaxel arm compared to paclitaxel suggestive of better QoL on Cabazitaxel. Conclusions: 3 weekly cabazitaxel as first line chemotherapy in HER2 negative MBC does not significantly improve PFS compared to weekly paclitaxel, though it has a lower risk of peripheral neuropathy with better patient reported overall health outcomes. Cabazitaxel is safe and well tolerated for MBC and requires fewer hospital visits, an important consideration in the COVID pandemic and beyond. Clinical trial information: NCT03048942 .

Time to first-line chemotherapy and travel distance to the cancer center and their relationship to subsequent-line therapies in stage IV CRC.

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 724-724
Author(s):  
Mahjabeen Fatima Iqbal ◽  
Aleksi Emil Suo ◽  
Neha Papneja ◽  
Nayyer Iqbal ◽  
Tahir Abbas ◽  
...  
Keyword(s):  
Performance Status ◽  
Stage Iv ◽  
Travel Distance ◽  
Cancer Center ◽  
First Line ◽  
Ecog Performance Status ◽  
Third Line ◽  
Ecog Ps ◽  
Improvement In Survival ◽  
Line Chemotherapy

724 Background: Second and third line therapies in stage IV colorectal (CRC) have been associated with significant improvement in survival. However, not all patients receive all available therapies. Delay in starting treatment and travel burden can affect patient access and use of future therapy. Little is known about time to first line chemotherapy (TC) and travel distance to cancer center (TD) and their relationship to future therapies in stage IV CRC. The study aims to determine relationship between TC and TD with second and subsequent line of therapies. Methods: A patients cohort diagnosed with synchronous stage IV CRC during 2006-2010 in the province of Saskatchewan, Canada was studied. Patients with ECOG performance status of > 1 or who did not receive chemotherapy were excluded. The logistic regression analyses were performed to assess relationship between TC and TD and subsequent line therapies. Results: 569 patients were diagnosed with synchronous stage IV CRC. 326 patients received first line chemotherapy (mostly FOLFIRI ± bevacizumab). Of 326 patients 62 with ECOG performance status (PS) > 1 were excluded. The median age of 264 eligible patients was 62 yrs (IQR:53-72). 61% were male and 38% had ECOG PS of 0. Mean Charlson score was 9±1.3. 24% underwent metastasectomy. Median TC was 77 days (IQR: 53-107) and median TD was 64.4 km (IQR:4.8-166). 42.8% patients had to travel > 100 km for their treatment. Of 326 patients 144 (55%) received future therapies. On multivariate analysis absence of comorbid illness (as per Charlson comorbid index), odd ratio (OR) 1.45 (95% CI: 1.19-1.77), no metastasectomy, OR 1.89 (1.03-3.46) and TD < 100 km, OR 1.69 (1.003-2.84) were correlated with the utility of 2ndand subsequent line therapies. Conclusions: Our result revealed that although time to first line chemotherapy did not correlate with future systemic therapies, travel distance to Cancer Center > 100 km was associated with low rate of second or subsequent line therapies in statge IV CRC patients with good performance status.

scholarly journals Real-World Assessment of Health Care Costs for Patients with Metastatic Pancreatic Cancer Following Initiation of First-Line Chemotherapy

2020 ◽  
Vol 26 (7) ◽  
pp. 872-878
Author(s):  
Andrea Bullock ◽  
Christopher G. Rowan ◽  
Nina Oestreicher ◽  
Homa Yeganegi ◽  
E. Gabriela Chiorean
Keyword(s):  
Health Care ◽  
Pancreatic Cancer ◽  
Health Care Costs ◽  
Real World ◽  
Metastatic Pancreatic Cancer ◽  
First Line ◽  
Care Costs ◽  
Line Chemotherapy

First-line nivolumab (NIVO) plus ipilimumab (IPI) plus two cycles of chemotherapy (chemo) versus chemo alone (4 cycles) in patients with advanced non-small cell lung cancer (NSCLC): Two-year update from CheckMate 9LA.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 9000-9000
Author(s):  
Martin Reck ◽  
Tudor-Eliade Ciuleanu ◽  
Manuel Cobo ◽  
Michael Schenker ◽  
Bogdan Zurawski ◽  
...  
Keyword(s):  
Clinical Benefit ◽  
Performance Status ◽  
Objective Response ◽  
Stage Iv ◽  
Progression Free Survival ◽  
Expression Level ◽  
First Line ◽  
Ecog Performance Status ◽  
Grade 3

9000 Background: In the randomized phase 3 CheckMate 9LA trial (NCT03215706), first-line NIVO + IPI combined with 2 cycles of chemo significantly improved overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) vs chemo alone (4 cycles). Clinical benefit was observed regardless of programmed death ligand 1 (PD-L1) expression level and histology. Here we report data with 2 years’ minimum follow-up from this study. Methods: Adult patients (pts) with stage IV / recurrent NSCLC, ECOG performance status ≤ 1, and no known sensitizing EGFR/ALK alterations were stratified by PD-L1 (< 1% vs ≥ 1%), sex, and histology (squamous vs non-squamous) and were randomized 1:1 to NIVO 360 mg Q3W + IPI 1 mg/kg Q6W + chemo (2 cycles; n = 361) or chemo alone (4 cycles; n = 358). Pts with non-squamous NSCLC in the chemo-alone arm could receive pemetrexed maintenance. The primary endpoint was OS. Secondary endpoints included PFS and ORR by blinded independent central review, and efficacy by different PD-L1 levels. Safety was exploratory. Results: At a minimum follow-up of 24.4 months for OS (database lock: Feb 18, 2021), pts treated with NIVO + IPI + chemo continued to derive OS benefit vs chemo, with a median OS of 15.8 months vs 11.0 months, respectively (HR, 0.72 [95% CI, 0.61–0.86]); 2-year OS rates were 38% vs 26%. Median PFS with NIVO + IPI + chemo vs chemo was 6.7 months vs 5.3 months (HR, 0.67 [95% CI, 0.56–0.79]); 8% and 37% of pts who had disease progression received subsequent immunotherapy, respectively. ORR was 38% with NIVO + IPI + chemo vs 25% with chemo. Similar clinical benefit with NIVO + IPI + chemo vs chemo was observed in all randomized pts and across the majority of subgroups, including by PD-L1 expression level (Table) or histology. Any grade and grade 3–4 treatment-related adverse events were reported in 92% and 48% of pts in the NIVO + IPI + chemo arm vs 88% and 38% in the chemo arm, respectively. Conclusion: With 2 years’ minimum follow-up, first-line NIVO + IPI + chemo demonstrated durable survival and benefit versus chemo in pts with advanced NSCLC; no new safety signals were identified. Clinical trial information: NCT03215706. [Table: see text]

scholarly journals Promising Immunotherapy in Metastatic Testicular Sex Cord Stromal Tumours After First-Line Chemotherapy

2022 ◽  
Vol 12 ◽  
Author(s):  
Bingqing Shang ◽  
Chuanzhen Cao ◽  
Weixing Jiang ◽  
Hongzhe Shi ◽  
Xingang Bi ◽  
...  
Keyword(s):  
Adverse Events ◽  
Checkpoint Inhibitors ◽  
Objective Response ◽  
Chemotherapy Resistance ◽  
Progression Free Survival ◽  
Retroperitoneal Lymph Node Dissection ◽  
First Line ◽  
Experienced Grade ◽  
Line Chemotherapy

BackgroundTesticular sex cord stromal tumours (TSCSTs) are rare, with few studies focusing on the metastatic TSCST prognosis. The value of treatments, including radical orchiectomy (RO) and retroperitoneal lymph node dissection (RPLND), in preventing metastasis is controversial. Additionally, metastatic TSCSTs are resistant to chemotherapy. We aimed to assess the effectiveness and safety of immunotherapy in metastatic TSCSTs after first-line chemotherapy.MethodsWe retrospectively screened patients with testicular tumours undergoing testis surgery between January 2005 and January 2019. Patients with TSCSTs who had undergone testis-sparing surgery (TSS) or RO were identified. The malignant type was defined as metastasis confirmed by pathology. Treatment responses, progression-free survival (PFS), overall survival (OS) and safety were analysed.ResultsAmong the 494 testicular tumour patients who received TSS or RO, 11 (2.2%) patients with histologically proven TSCSTs were identified. At the last follow-up, 7 patients survived without tumours, and 4 patients developed metastasis and received first-line cisplatin-based chemotherapy, with 1 of them achieving an objective response. Their PFS times were 1.5, 2.2, 9.0, and 17.0 months, respectively. Two patients received immune checkpoint inhibitors (ICIs) after developing chemotherapy resistance and achieved a partial response up to the last follow-up; one of them experienced Grade 1 adverse events, and the other experienced Grade 2 adverse events during immunotherapy. The median OS time of the 4 patients with metastatic TSCSTs was 32 months.ConclusionsTSCSTs are rare, and most are benign with a good prognosis. ICIs represent a promising option for improving clinical outcomes in metastatic TSCSTs.

Update results from ALTER-C-001: Efficacy and safety of anlotinib plus XELOX regimen as first-line treatment followed by maintenance monotherapy of anlotinib for patients with mCRC-A single-arm, multicenter, phase Ⅱ clinical trial.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e15550-e15550
Author(s):  
Jin Yan ◽  
Yunwei Han ◽  
Li Zhang ◽  
Yongdong Jin ◽  
Hao Sun
Keyword(s):  
Clinical Trial ◽  
Adverse Events ◽  
Performance Status ◽  
Phase Iii ◽  
Line Treatment ◽  
First Line ◽  
Open Label ◽  
Ecog Performance Status ◽  
Multicenter Phase ◽  
First Line Treatment

e15550 Background: The combination of anti-VEGF or anti-EGFR targeted drugs with chemotherapy is the standard first-line therapy for metastatic colorectal cancer (mCRC), and the followed maintenance treatment is an optional approach to balance the efficacy and toxicity. However, studies regarding the maintenance strategies based on antiangiogenic TKIs are limited currently. Anlotinib, a novel oral multi-target TKI which can inhibit both tumor angiogenesis and tumor cell proliferation simultaneously, substantially prolonged the PFS with manageable toxicity for refractory mCRC in the phase III ALTER0703 clinical trial. Here we report an update on the effectiveness and safety of anlotinib plus XELOX as first-line treatment followed by anlotinib monotherapy for mCRC. Methods: In this open label, single-arm, multicenter phase II clinical trial, 53 mCRC patients without prior systemic treated, aged 18-75 and an ECOG performance status of 0 or 1 were planned to recruit. Eligible patients received capecitabine (1000 mg/m2, po, d1-14, q3w) and oxaliplatin (130 mg/m2, iv, d1, q3w) plus anlotinib (10mg, po, d1̃14, q3w) treatment for 6 cycles. After 6 cycles of inducing therapy, patients would receive anlotinib (12mg, po, d1̃14, q3w) as maintenance therapy until disease progression or intolerable adverse events (AEs). The primary endpoint was PFS; Secondary endpoints included ORR, DCR, DOR and safety. Results: By the data analysis cutoff date of January 22, 2021, a total of 18 patients were enrolled, of which 12 patients were available for efficacy assessment. In best overall response assessment, there were 50.0% PR (6/12), 33.3% SD (4/12) and 16.7% PD (2/12). The ORR was 50.0% (95% CI, 21.1-78.9%) and DCR was 83.3% (95% CI, 51.5-97.9%). The longest duration of treatment was 8.8 months and the response was still ongoing. The median PFS was not reached. The most common treatment related adverse events (TRAEs) of any grade (≥20%) were leukopenia, hypertension, neutropenia, diarrhea, fatigue, hypertriglyceridemia. Grade 3/4 TRAEs included hypertension (22.2%), hypertriglyceridemia (11.1%), lipase elevated (11.1%) and neutropenia (5.6%). No grade 5 AEs occurred. Conclusions: The update results suggested that anlotinib combined with XELOX as first line regimen followed by anlotinib monotherapy showed promising anti-tumor activity and manageable safety for patients with mCRC. And the conclusions needed to be confirmed in trials continued subsequently. Clinical trial information: ChiCTR1900028417.

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.

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