scholarly journals Liposomal irinotecan (nal-IRI) plus 5-fluorouracil/levoleucovorin (5 FU/LV) vs 5-FU/LV in Japanese patients (pts) with gemcitabine-refractory metastatic pancreatic cancer (mPAC)

2019 ◽  
Vol 30 ◽  
pp. ix47-ix48 ◽  
Author(s):  
T. Ioka ◽  
S. Nakamori ◽  
K. Sugimori ◽  
M. Kanai ◽  
M. Ikeda ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Japanese Patients ◽  
Metastatic Pancreatic Cancer ◽  
Gemcitabine Refractory ◽  
Liposomal Irinotecan

Dispersion in total cost of care for Medicare fee-for-service (FFS) patients with metastatic pancreatic cancer receiving FDA-approved/NCCN Category 1 regimens at 340B verus non-340B institutions.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18843-e18843
Author(s):  
Helen Latimer ◽  
Samantha Tomicki ◽  
Gabriela Dieguez ◽  
Paul Cockrum ◽  
George P. Kim
Keyword(s):  
Pancreatic Cancer ◽  
Cost Of Care ◽  
Metastatic Pancreatic Cancer ◽  
Fee For Service ◽  
Total Cost ◽  
Diagnosis Codes ◽  
Heavily Pretreated ◽  
Icd 10 ◽  
Liposomal Irinotecan ◽  
Line Of Therapy

e18843 Background: The Department of Health and Human Services (HHS) designed the 340B drug pricing program to allow institutions that service specialty populations to acquire drugs at lower prices. Objective: To analyze the dispersion in total cost of care (TCOC) for Medicare FFS patients (pts) with metastatic pancreatic cancer (m-PANC) treated at 340B or non-340B institutions, by NCCN Category 1 regimen. Methods: We identified pts with m-PANC using ICD-10 diagnosis codes in the 2016-18 Medicare Parts A/B/D 100% Research Identifiable Files. Study pts had 2+ claims with a pancreatic cancer diagnosis and Medicare FFS coverage for 6 months pre- and 3 months post-metastasis diagnosis. Study pts were treated with NCCN Category 1 regimens: 1L gemcitabine monotherapy (gem-mono), 1L gemcitabine/nab-paclitaxel (gem-nab), 1L FOLFIRINOX (FFX), and 2L liposomal irinotecan-based regimen (nal-IRI). Pts were attributed to 340B or non-340B institutions based on plurality of chemotherapy claims. TCOC reflects insurer-paid services per line of therapy (LOT) for 3 categories: chemotherapy/supportive drugs (chemo/Rx), inpatient care (IP), and other outpatient care (OP). We grouped pts by quartile (qrt) and evaluated drivers of TCOC and mean rates of admissions (admits/pt). Results: We identified 2,697 (340B) and 3,839 (non-340B) pts taking NCCN Category 1 regimens. Gem-mono represented 1% and 4% of all pts in 340B and non-340B institutions, respectively. Gem-nab accounted for 72% of pts in both cohorts. For gem-nab, FFX, and nal-IRI pts, median TCOC was similar in both cohorts, although mean TCOC by qrt was lower at 340B institutions than non-340B institutions, except for gem-nab in the 1st qrt. The components of TCOC were similar between 340B and non-340B institutions in all qrts. In both cohorts, % IP costs increased between the 1st and 4th qrt (340B:15% to 23%, non-340B:14% to 25%). From the 1st to the 4th qrt, admits/pt increased in both cohorts. In the 340B cohort, nal-IRI pts had the lowest admits/pt while gem-nab pts had the highest in all qrts. In the non-340B cohort, nal-IRI pts had the lowest admits/pt except for in the 1st qrt. Conclusions: Median TCOC was lower at 340B institutions than non-340B institutions for all regimens, and the range of TCOC dispersion was also smaller at 340B institutions. Across qrts, chemotherapy accounted for approximately half the TCOC; however, IP costs were proportionally higher in the 4th qrt. Comparing regimens, despite 2L nal-IRI pts being more heavily pretreated, median costs in each cohort were similar to 1L gem-nab and 1L FFX, while admits/pt were generally lower than 1L gem-nab and 1L FFX across qrts and cohorts.

scholarly journals Oral mTOR Inhibitor Everolimus in Patients With Gemcitabine-Refractory Metastatic Pancreatic Cancer

2009 ◽  
Vol 27 (2) ◽  
pp. 193-198 ◽  
Author(s):  
Brian M. Wolpin ◽  
Aram F. Hezel ◽  
Thomas Abrams ◽  
Lawrence S. Blaszkowsky ◽  
Jeffrey A. Meyerhardt ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Adverse Events ◽  
Single Agent ◽  
Progression Free Survival ◽  
Mtor Inhibitors ◽  
Mtor Pathway ◽  
Metastatic Pancreatic Cancer ◽  
Clinical Activity ◽  
Antitumor Effects ◽  
Gemcitabine Refractory

PurposeThe PI3K/Akt/mTOR pathway is activated in the majority of pancreatic cancers, and inhibition of this pathway has antitumor effects in preclinical studies. We performed a multi-institutional, single-arm, phase II study of RAD001(everolimus), an oral inhibitor of mTOR, in patients who experienced treatment failure on first-line therapy with gemcitabine.Patients and MethodsThirty-three patients with gemcitabine-refractory, metastatic pancreatic cancer were treated continuously with RAD001 at 10 mg daily. Prior treatment with fluorouracil in the perioperative setting was allowed. Patients were observed for toxicity, treatment response, and survival.ResultsTreatment with single-agent RAD001 was well-tolerated; the most common adverse events were mild hyperglycemia and thrombocytopenia. No patients were removed from the study because of drug-related adverse events. No complete or partial treatment responses were noted, and only seven patients (21%) had stable disease at the first restaging scans performed at 2 months. Median progression-free survival and overall survival were 1.8 months and 4.5 months, respectively. One patient (3%) had a biochemical response, defined as ≥ 50% reduction in serum CA19-9.ConclusionAlthough well-tolerated, RAD001 administered as a single-agent had minimal clinical activity in patients with gemcitabine-refractory, metastatic pancreatic cancer. Future studies in metastatic pancreatic cancer should assess the combination of mTOR inhibitors with other agents and/or examine inhibitors of other components of the PI3K/Akt/mTOR pathway.

A phase II study of S-1 in gemcitabine-refractory metastatic pancreatic cancer

2008 ◽  
Vol 63 (2) ◽  
pp. 313-319 ◽  
Author(s):  
Chigusa Morizane ◽  
Takuji Okusaka ◽  
Junji Furuse ◽  
Hiroshi Ishii ◽  
Hideki Ueno ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Metastatic Pancreatic Cancer ◽  
Gemcitabine Refractory

Gemcitabine + cisplatin (GEM+CIS) in combination with regional hyperthermia (RHT) in second-line therapy of gemcitabine-refractory metastatic pancreatic cancer

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 14073-14073
Author(s):  
K. E. Tschoep ◽  
V. Milani ◽  
G. Schmidt ◽  
X. Schiel ◽  
S. Abdel-Rahman ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Phase Iii ◽  
Metastatic Pancreatic Cancer ◽  
Regional Hyperthermia ◽  
System A ◽  
Line Therapy ◽  
Metastatic Pancreatic Adenocarcinoma ◽  
Progression Of Disease ◽  
Prospective Phase ◽  
Gemcitabine Refractory

14073 Background: Our completed phase III trial comparing GEM + CIS vs. GEM alone showed good efficacy for the combination arm in 1st-line therapy (ASCO abstr. No. 1003, 2003). Based on the rationale of chemosensitization of CIS by RHT we are performing a prospective phase II study with GEM + CIS combined with RHT. Methods: Until 8/2005 12 pts with metastatic pancreatic adenocarcinoma who failed GEM-based 1st-line-therapy were enrolled in this study. One cycle consisted of GEM (1000mg/m2) on d1 followed by CIS (25mg/m2) on d2 and d4 combined with RHT (BSD system). A total of 2 blocks each of 4 cycles were given biweekly. The main endpoints were time to second progression (TTP2) and 1-year event free survival (1-yr-EFS). TTP2 and EFS were defined as time from start of 2nd-line therapy until progression of disease or death. Response (RECIST) was evaluated after 4 and 8 cycles of therapy. Results: Pt characteristics: median age 60; M:F=8:4. Median time to first progression (TTP1) was 6 months (95% CI:2–7). 8/12 pts received all 8 cycles. No toxic death and no grade 4 toxicity occurred. In 12/2005 10/12 pts were evaluable for this study. Control of disease (1CR, 2MR, 4NC) and progression (3PD) occurred in 70% and 30% respectively. The median TTP2 is 8 months (95% CI: 2–13) and the 1-yr-EFS is 32% (95% CI:3–61). 7 pts are alive at 12/2005. Conclusions: Our ongoing study (EudraCT-No 2005–003855–11) using RHT combined with GEM + CIS shows promising antitumor activity with a very encouraging TTP2 and median 1-yr-EFS in the 2nd-line treatment of GEM-refractory metastatic pancreatic cancer. [Table: see text]

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