Real world hospital costs associated with nab-paclitaxel plus gemcitabine (nab-P+G) and FOLFIRINOX (FFX) as first line (1L) treatment (tx) for metastatic pancreatic adenocarcinoma (MPAC).
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e15741 Background: In independent phase III trials, both nab-P+G and FFX demonstrated superiority over G as 1L MPAC tx. Limited data exist on real world effectiveness and costs of nab-P+G v FFX. This study compared median time to tx discontinuation (TTD) and costs between the two cohorts. Methods: A retrospective study was conducted with MedAssets’ de-identified US hospital data. Patients (pts) ≥ 18 yo diagnosed with MPAC between 04/13 and 02/15, completing ≥ 1 cycle of nab-P+G or FFX as 1L, and with ≥ 6 months of data were included. Primary endpoints were median TTD and total costs. Supportive care use and costs were also examined. Between group comparisons used Kaplan-Meier (TTD) and ANOVA (costs). Multivariable general linear regression with gamma distributions were used for costs. Results: A total of 89 pts received nab-P+G, while 61 received FFX. nab-P+G pts were older (age ≥ 70: 31.5% v 11.5%; p < 0.05) compared to FFX, though Charlson Comorbidity Indices were similar (nab-P+G = 8.8, FFX = 9.0). More nab-P+G pts were treated in teaching (56% v 49%) and < 200 bed facilities (27% v 21%), but these differences were not significant. Median TTD did not differ significantly between nab-P+G (120 days) and FFX (98 days; p = 0.77). Median costs per month of tx were lower in nab-P+G pts ($12,192 v $18,743, p < 0.01). More FFX pts used GCSF (66.7% v 22.5%, p < 0.01), while more nab-P+G pts used blood products (BP) (30.0 v 10.4%, p < 0.05). Monthly GCSF and antiemetic costs were lower in nab-P+G pts ($1,584 v $4,793, p < 0.05; $595 v $1,351, p < 0.05). Multivariable analysis confirmed higher total costs (IRR = 1.4, p < 0.01), GCSF costs (IRR = 2.5, p < 0.05) and antiemetic costs (IRR = 6.4, p < 0.01) in FFX pts. No significant differences were seen in BP costs between cohorts. Monthly inpatient costs were lower for nab-P+G ($510 v $3,503, p < 0.01) but not significant (p = 0.18) when controlling for baseline variables. Conclusions: While median TTD was similar between nab-P+G and FFX cohorts, pts treated with FFX had higher total costs driven in part by use of GCSF, antiemetics, and inpatient visits.Keywords:
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FOLFIRINOX
There are no randomized data to guide treatment decisions for patients with advanced pancreatic adenocarcinoma following first-line FOLFIRINOX. We performed a systematic review and meta-analysis of studies using gemcitabine-based chemotherapy after FOLFIRINOX to assess treatment efficacy and toxicity.We included studies published between 2011 and 2018 that evaluated the efficacy and toxicity of gemcitabine-based chemotherapy after FOLFIRINOX in patients with advanced pancreatic adenocarcinoma. We searched PubMed, Embase, Scopus, and Web of Science. Primary outcomes were objective response rate (ORR), disease control rate (DCR), any grade 3/4 toxicity rate, and progression-free survival (PFS). We used the random-effects model to generate pooled estimates for proportions.Sixteen studies met the eligibility criteria. Overall, ORR was 10.8%, DCR was 41.1%, and any grade 3/4 toxicity rate was 28.6%. In subgroup analyses, gemcitabine plus nab-paclitaxel was associated with superior ORR (14.4 versus 8.4%; p = 0.038) and DCR (53.5 versus 30.5%; p < 0.001) compared with single-agent gemcitabine. Median PFS ranged from 1.9 to 6.4 months and numerically favored gemcitabine plus nab-paclitaxel.Our study suggests gemcitabine-based chemotherapy likely outperforms best supportive care after FOLFIRINOX in advanced pancreatic cancer. Also, gemcitabine plus nab-paclitaxel seems to be more active than single-agent gemcitabine (CRD42018100421).
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Standard treatment for advanced pancreatic cancer has had minimal impact on natural course of the disease. Current standard chemotherapy for healthy, robust patients remains FOLFIRINOX (5fluorouracil, leucovorin, oxaliplatin, and irinotecan) chemotherapy which showed 4-month overall survival benefit compared to gemcitabine alone [2]. Recently MPACT study showed that adding nabpaclitaxel to gemcitabine significantly improved overall survival compared to gemcitabine (8.5 months vs. 6.7 months P=0.000015). However, the combination remains more toxic compared to gemcitabine [3].
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Gemcitabine is among the standard first-line agents for the treatment of metastatic pancreatic cancer. However, as the median survival with gemcitabine monotherapy is 6 months, different combinations are being studied for better, prolonged survival. In this multicenter study, we aimed to compare the results of gemcitabine monotherapy with those of gemcitabine and cisplatin combination therapy as first-line treatments for metastatic pancreatic cancer.Data of 664 patients diagnosed with metastatic pancreatic cancer between January 2007 and December 2016 from seven oncology centers in Turkey were retrospectively evaluated, and 319 patients with gemcitabine alone (n=138) or gemcitabine and cisplatin combination (n=181) as first-line treatment were included.The median patient age was 62 years (range 42-79), being 60 years (42-75) in the gemcitabine/cisplatin arm and 67 years (52-79) in gemcitabine alone arm. no complete response was observed in either arm, whereas partial response rates were 30.1% in gemcitabine/cisplatin arm and 15.3% in gemcitabine alone arm (p=0.001). median overall survival was 8 months (95% CI:7.7-10.2) and was significantly longer in the gemcitabine/cisplatin arm than in the gemcitabine alone arm (10 vs. 6 months, p=0.004).The cemcitabine and cisplatin combination therapy as first-line treatment of metastatic pancreatic cancer yields significantly prolonged survival over gemcitabine monotherapy. In patients with favorable performance conditions, the combination therapy should be preferred.
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Introduction: Despite a clinically relevant, statistically significant survival benefit with nab -paclitaxel plus gemcitabine and FOLFIRINOX vs single-agent gemcitabine for metastatic pancreatic cancer (mPC), little is known regarding their real-world effectiveness. We analyzed patients with mPC using a nationally representative electronic medical records database to address this unmet need. Methods: This retrospective analysis of the Navigating Cancer database compared outcomes among patients who received first-line nab -paclitaxel plus gemcitabine, FOLFIRINOX, or gemcitabine for mPC. Effectiveness, safety, and supportive care use were examined. nab -Paclitaxel plus gemcitabine was the reference for statistical comparisons. Results: Baseline characteristics were similar except age (oldest patients were in the gemcitabine cohort followed by nab -paclitaxel plus gemcitabine, then FOLFIRINOX). Patients receiving nab -paclitaxel plus gemcitabine (n=122) demonstrated similar time to treatment discontinuation (TTD; median, 3.4 vs 3.8 months; P =0.947) and database persistence (DP; median, 8.6 vs 8.6 months; P =0.534) vs FOLFIRINOX (n=80); however, TTD (median, 3.4 vs 2.2 months; P <0.001) and DP (median, 8.6 vs 5.3 months; P =0.030) were significantly longer with nab -paclitaxel plus gemcitabine vs gemcitabine (n=46). There were more any-grade adverse events with FOLFIRINOX or gemcitabine vs nab -paclitaxel plus gemcitabine (95% or 89% vs 84%, respectively). Conclusion: This real-world analysis confirms the phase III MPACT trial findings and demonstrates that nab -paclitaxel plus gemcitabine has effectiveness similar to that of FOLFIRINOX but greater tolerability for treating mPC despite younger patients being in the FOLFIRINOX cohort. These findings support nab -paclitaxel plus gemcitabine as an appropriate first-line treatment option for patients with mPC. Keywords: metastatic pancreatic cancer, nab -paclitaxel, gemcitabine, FOLFIRINOX, comparative effectiveness
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The present study aimed to evaluate the clinical benefits of leucovorin, 5‑fluorouracil, irinotecan and oxaliplatin (FOLFIRINOX) vs. gemcitabine plus Nab‑paclitaxel (GnP) as a first‑line therapy for patients with inoperable pancreatic cancer. For this purpose, in‑house data available for 45 patients who received FOLFIRINOX or GnP as first‑line treatment between 2014 and 2019 were retrospectively analyzed. In total, 21 and 24 patients received FOLFIRINOX and GnP, respectively. Although there were no significant differences in the median progression‑free survival, the median overall survival was longer in the FOLFIRINOX group than in the GnP group (16.7 vs. 7.2 months). A total of 14 patients received FOLFIRINOX followed by GnP, whereas 3 patients received GnP followed by FOLFIRINOX. All patients who did not switch to second‑line therapy owing to poor feasibility were included in the GnP group. The data indicated that patients receiving GnP as first‑line therapy were less likely to switch to FOLFIRINOX and, consequently, had a worse prognosis.
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e15796 Background: FOLFIRINOX is well known to be a highly effective treatment in pancreatic cancer for young patients with good performance status. As the original ACCORD study was carried out with patient’s performance status 0 or 1, many oncologists feel uncertain administering modified dose FOLFIRINOX (m-FOLFIRINOX) as a second-line therapy. We have previously reported our experience in 35 patients (aged 27 – 85) where we concluded that m-FOLFIRINOX can be administered safely with appropriate dose reductions. More recently, the systematic review and meta-analysis by Tong et al. concluded that m-FOLFIRINOX is a good choice of therapy even for those with poor performance status. This retrospective analysis assessed the efficacy of m-FOLFIRINOX in second-line treatment of pancreatic adenocarcinoma. Methods: Using an electronic database, patients with either locally advanced or metastatic pancreatic adenocarcinoma were identified who had received first-line gemcitabine plus nab-paclitaxel, followed by second-line m-FOLFIRINOX between January 2013 and July 2018. All patients had an ECOG performance status of 2 or less. Overall survival (OS) was estimated by the Kaplan-Meier method. Results: Fifty-two patients were identified, with 65% of the patients having metastatic pancreatic disease. Median age of patients was 75 (range, 27 – 86). Dose intensity of m-FOLFIRINOX was 65% for oxaliplatin, 68% for irinotecan, 18% for bolus 5-fluorouracil (5-FU) and 68% for infusional 5-FU. From diagnosis, the median OS of all patients was 45.0 months (95% CI, 25.0 – 63.0). The median OS of the locally advanced and metastatic pancreatic adenocarcinoma was 63.0 months (95% CI, 45.0 – 70.0) and 22.5 months (95% CI, 18.0, 38.0), respectively. Conclusions: Our study demonstrates the safety and efficacy of m-FOLFIRINOX as a second-line therapy after gemcitabine plus nab-paclitaxel failure. These findings correlate with the findings of Tong et al.’s findings of the benefits of m-FOLFIRINOX for advanced pancreatic cancer in patients with poor performance status.
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Purpose Since the combination of cisplatin plus gemcitabine (CG) had a significant survival advantage for the treatment of patients with chemotherapy-naïve advanced or metastatic non-small cell lung cancer (NSCLC), CG combination have been evaluated with different schedules. However, the best schedule is still unclear. We designed to compare the efficacy and toxicity of CG combination chemotherapy in two different doses of gemcitabine (1,000 or 1,250 mg/m2 3-weekly). Materials and Methods We randomized patients with stage III or IV NSCLC into either gemcitabine 1,250 mg/m2 or gemcitabine 1,000 mg/m2. Patients received cisplatin 60 mg/m2 intravenously on day1 of each 3-week cycle. Gemcitabine was administered intravenously on days 1 and 8 of each 3-week cycle. Results From April 2002 until July 2004, 125 patients were enrolled from four university hospitals (55 patients in the gemcitabine 1,000 mg/m2 arm and 70 patients in the gemcitabine 1,250 mg/m2 arm). Response rates were not significantly different in both arms (56.4% vs. 55.7%). However, grade 3 neutropenia was significantly lower in gemcitabine 1,000 mg/m2 arm compared to gemcitabine 1,250 mg/m2 arm (11.0% vs. 15.8%). No differences in non-haematologic toxicities in both arms except anorexia were observed. The median survival was 13.4 months for gemcitabine 1,000 mg group compared with 15.8 months for gemcitabine 1,250 mg group. There were no statistically significant differences in survival between the groups. Conclusion For stage III or IV non-small cell lung cancer, combination chemotherapy with gemcitabine 1,000 mg/m2 showed equivalent response rate with lesser neutropenia and anorexia compared to treatment with gemcitabine 1,250 mg/m2.
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Background: Pancreatic cancer is a highly aggressive cancer. According to the latest data published by the World Health Organization, the number of new cases in 2020 in Iraq was 674 and represented 2% of all new cancer cases. Most of the pancreatic adenocarcinomas have spread outside the pancreas at the time of diagnosis. Progression free survival is the time between the date of diagnosis to disease progression or death. The current study aims to compare progression free survival between three chemotherapy regimens; Gemcitabine, Gemcitabine/Nab-paclitaxel and FOLFIRINOX of advanced and metastatic pancreatic cancer in Iraqi patients. Methods: Patients were divided into three groups; patients who will receive Gemcitabine, those who will receive Gemcitabine/Nab-paclitaxel, and patients who will receive FOLFIRINOX. The patients were observed for disease progression by computed tomography which was performed every three months for the tumor response and progression. Results: In the Gemcitabine, Gemcitabine/Nab-paclitaxel, and FOLFIRINOX groups, the median Progression Free Survivals were (4, 5, and 5.7 months, respectively; p is less than 0.05), where FOLFIRINOX was superior to Gemcitabine monotherapy and Gemcitabine/Nab-paclitaxel. In addition, neutropenia, febrile neutropenia, diarrhoea, nausea, vomiting, fatigue, hypokalaemia and neuropathy were highly in the FOLFIRINOX-treated patients than in both Gemcitabine and Gemcitabine/Nab-paclitaxel groups of patients. However, anaemia and thrombocytopenia were higher with Gemcitabine and Gemcitabine/Nab-paclitaxel than were with FOLFIRINOX. Conclusion: The median Progression free survival is better for the Gemcitabine/Nab-paclitaxel and FOLFIRNOX than for Gemcitabine alone. Also, adverse effects are more common with FOLFIRINOX than with other first-line chemotherapeutic agents.
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Abstract Background Trials examining FOLFIRINOX in metastatic pancreatic cancer demonstrate higher response rates compared to gemcitabine‐based regimens. There is currently limited experience with neoadjuvant FOLFIRINOX in pancreatic cancer. Methods Retrospective review of outcomes of patients with borderline resectable or locally unresectable pancreatic cancer who were recommended to undergo neoadjuvant treatment with FOLFIRINOX. Results FOLFIRINOX was recommended for 25 patients with pancreatic cancer, 13 (52%) unresectable and 12 (48%) borderline resectable. Four patients (16%) refused treatment or were lost to follow‐up. Twenty‐one patients (84%) were treated with a median of 4.7 cycles. Six patients (29%) required dose reductions secondary to toxicity. Two patients (9%) were unable to tolerate treatment and three patients (14%) had disease progression on treatment. Seven patients (33%) underwent surgical resection following treatment with FOLFIRINOX alone, 2 (10%) of which were initially unresectable. Two patients underwent resection following FOLFIRINOX + stereotactic body radiation therapy (SBRT). The R0 resection rate for patients treated with FOLFIRINOX ± SBRT was 33% (55% borderline resectable, 10% unresectable). A total of five patients (24%) demonstrated a significant pathologic response. Conclusions FOLFIRINOX is a biologically active regimen in borderline resectable and locally unresectable pancreatic cancer with encouraging R0 resection and pathologic response rates. J. Surg. Oncol. 2013 108:236–241 . © 2013 Wiley Periodicals, Inc.
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The systemic administration of gemcitabine has been accepted as the first standard treatment for patients with advanced pancreatic cancer. The survival of patients treated by gemcitabine, however, is still unsatisfactory. To improve the anti-tumor effect of gemcitabine, we investigated molecular changes by gemcitabine in in vitro and in vivo pancreatic cancer models. The findings suggested that administering gemcitabine after 5-FU may be the optimal combination of gemcitabine/5-FU treatment for pancreatic cancer. Furthermore, a study with gemcitabine resistant pancreatic cancer cells using both in vitro and clinical models indicated that ribonucleotide reductase M1 subunit would be a key molecule in gemcitabine resistance in human pancreatic cancer and that RRM1 could have potential as a predictor and modulator of gemcitabine treatment.
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