Second-Line Treatment With a Combination of Continuous 5-Fluorouracil, Doxorubicin, and Mitomycin-C (Conti-Fam) in Gemcitabine-Pretreated Pancreatic and Biliary Tract Cancer

Lee, Suee; Oh, Sung Yong; Kim, Byung Geun; Kwon, Hyuk‐Chan; Kim, Sung-Hyun; Rho, Myung Hwan; Kim, Young-Hoon; Rho, Mee-Sook; Jeong, J.; Kim, Hyojin

doi:10.1097/coc.0b013e31818c08ff

Cited by 55 publications

(42 citation statements)

References 22 publications

(36 reference statements)

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“…FU therapy, gemcitabine based therapy, sunitinib, and imatinib are among those studied in the second-line setting (11)(12)(13)(14)(15)(16)(17)(18)(19)(20). Median time to progression (TTP) seen with these regimens ranged from 1.6 to 5.5 months.…”

Section: Discussionmentioning

confidence: 99%

Second-line systemic treatment for advanced cholangiocarcinoma.

Rogers

Law

Nguyen

et al. 2014

JCO

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Background: Gemcitabine plus platinum (GEM-P) combination chemotherapy is standard treatment for first-line advanced cholangiocarcinoma (aCC). GEM-P first-line therapy reports a progression-free survival (PFS) of 8 months and overall survival (OS) of 11.7 months. Treatment in the second-line setting is less clear.Five-year survival for aCC remains dismal at 5-10%. The purpose of this study was to describe the outcomes with second-line systemic treatment at our institution. Results: Fifty-six patients were included and the majority had intrahepatic aCC. A total of 80% received first-line gemcitabine-based therapy. Second-line therapy consisted of GEM-P (19.6%), GEM-FU (28.6%), FU-combo (37.5%), and others (14.3%). Median PFS was 2.7-month (95% CI, 2.3-3.8 months) with a median OS of 13.8 months (95% CI, 12-19.3 months) and a disease control rate of 50%. No significant difference in survival was identified between the four treatment groups.Conclusions: This study revealed a 2.7-month PFS, 50% disease control rate, and potential survival benefit with second-line treatment. Options for second-line systemic therapy include GEM-FU, FU-combo, GEM-P if not given in the first-line setting. Targeted therapy with erlotinib or bevacizumab could be considered in addition to chemotherapy.

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Section: Discussionmentioning

confidence: 99%

Second-line systemic treatment for advanced cholangiocarcinoma.

Rogers

Law

Nguyen

et al. 2014

JCO

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“…Standard second-line chemotherapies have not been proposed, although a number of new regimens are now investigated [35,36,37]. Recently, S-1, oral fluoropyrimidine derivatives, showed mild toxicity and modest efficacy for the treatment of BTC [38,39,40].…”

Section: Discussionmentioning

confidence: 99%

Renal Toxicity Associated with Weekly Cisplatin and Gemcitabine Combination Therapy for Treatment of Advanced Biliary Tract Cancer

Kobayashi¹,

Ueno²,

Ohkawa³

et al. 2014

Oncology

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Objective: A combination of weekly cisplatin plus gemcitabine is a new standard regimen for patients with advanced biliary tract cancer (BTC). This regimen does not require prolonged hydration schedules; however, the long-time safety profile has not been evaluated so far. In particular, the aim of this study was to evaluate the renal function during this regimen. Methods: We reviewed 79 consecutive patients with BTC who received the weekly cisplatin plus gemcitabine regimen. The incidence of adverse events was evaluated by CTCAE v4.0. Results: A total of 402 courses were administered. The median cumulative dose of cisplatin was 250 mg (range: 25-825). The renal function was exacerbated gradually throughout the treatment course. The incidence of a decreased glomerular filtration rate (GFR) at <50 ml/min was significantly related to a pretreatment GFR at <80 ml/min and a total dose of cisplatin >400 mg [p = 0.011, odds ratio (OR) 58.2, 95% confidence interval (CI): 2.5-1334.0 and p = 0.021, OR 18.3, 95% CI: 1.6-215.5]. Conclusions: The combination of weekly cisplatin and gemcitabine for advanced BTC gradually affected the renal function, and it was highly recommended to focus on both the change of GFR and total dose of cisplatin during this regimen.

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“…Because there is no established survival data for patients who have failed palliative chemotherapy for advanced BTC, survival data from a published phase II study in a similar clinical setting was used. Based on prior phase II trials, patients who failed prior chemotherapy had a 6-month survival rate of 15–30% and a median survival of 4–6 months [16,17,18,19]. Forty-four patients would be sufficient to discriminate between a 6-month survival rate of 20% (H0) and 32% (H1) with 75% power (one-sided alpha error: 0.05).…”

Section: Methodsmentioning

confidence: 99%

“…A salvage regimen to treat patients with previous GEM-based or 5-FU-based chemotherapy is imperative with an increasing proportion of patients who are in need of further systemic treatment, while maintaining a sufficient performance status (PS). There are only a few published studies which have investigated salvage chemotherapy in patients with advanced BTC after failure of GEM-based or 5-FU-based regimens [16,17,18,19]. …”

Section: Introductionmentioning

confidence: 99%

“…We hypothesized that a combination regimen of infusional 5-FU, doxorubicin and MMC (iFAM) would have additional benefits in patients with refractory advanced BTC. Although several studies have investigated prognostic factors for patients receiving first-line chemotherapy, limited data exist which have evaluated prognostic factors in a salvage setting [16,17]. …”

Section: Introductionmentioning

confidence: 99%

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Outcome of Infusional 5-Fluorouracil, Doxorubicin, and Mitomycin-C (iFAM) Chemotherapy and Analysis of Prognostic Factors in Patients with Refractory Advanced Biliary Tract Cancer

Lim¹,

Han²,

Oh³

et al. 2012

Oncology

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Objective: The purpose of this study was to determine the efficacy and safety of infusional 5-fluorouracil (5-FU), doxorubicin, and mitomycin-C (iFAM) as salvage chemotherapy in biliary tract cancer (BTC) and to identify prognostic factors. Methods: Fifty patients received 5-FU 800 mg/m² over 10 h on days 1–5, doxorubicin 30 mg/m² on day 1 and mitomycin-C 8 mg/m² on day 1, every 4 weeks. The primary endpoint was the overall survival (OS) rate at 6 months. Results: The responses to iFAM were as follows: partial response in 2 patients (4.2%) and stable disease in 9 patients (18.7%). The median progression-free survival and OS were 2.2 months and 5.6 months, respectively. The 6-month OS rate was 48%. Grade 3/4 adverse events included neutropenia (10%), thrombocytopenia (8%), and anemia (2%). Based on multivariate analysis, Eastern Cooperative Oncology Group (ECOG) performance status, serum albumin, and response to previous chemotherapy were significantly associated with OS. Three risk groups based on the number of 3 poor prognostic factors (0 vs. 1 vs. 2–3) were well correlated to OS (8.7 vs. 5.5 vs. 2.4 months, respectively; p = 0.0002). Conclusions: iFAM as salvage regimen has modest effect and tolerable toxicity in advanced BTC. The described risk group classification may help guide treatment plans.

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Second-Line Treatment With a Combination of Continuous 5-Fluorouracil, Doxorubicin, and Mitomycin-C (Conti-Fam) in Gemcitabine-Pretreated Pancreatic and Biliary Tract Cancer

Abstract: The conti-FAM regimen seems to constitute a safe and feasible salvage therapy in patients with advanced bilio-pancreatic cancer who had been treated previously via gemcitabine-based chemotherapy.

Cited by 55 publications

References 22 publications

Second-line systemic treatment for advanced cholangiocarcinoma.

Second-line systemic treatment for advanced cholangiocarcinoma.

Renal Toxicity Associated with Weekly Cisplatin and Gemcitabine Combination Therapy for Treatment of Advanced Biliary Tract Cancer

Outcome of Infusional 5-Fluorouracil, Doxorubicin, and Mitomycin-C (iFAM) Chemotherapy and Analysis of Prognostic Factors in Patients with Refractory Advanced Biliary Tract Cancer

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