Gemcitabine alone or in combination with cisplatin in patients with biliary tract cancer: a comparative multicentre study in Japan

Okusaka, Takuji; Nakachi, Kohei; Fukutomi, Akira; Mizuno, Nobumasa; Ohkawa, Shinichi; Funakoshi, Akihiro; Nagino, Masato; Kondo, Satoshi; Nagaoka, Soshi; Funai, Jumpei; Koshiji, Minori; Nambu, Yoshihiro; Furuse, Junji; Miyazaki, Masaru; Nimura, Yuji

doi:10.1038/sj.bjc.6605779

Cited by 618 publications

(529 citation statements)

References 22 publications

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“…A randomized phase II trial (BT22 trial) was carried out in Japan to evaluate both gemcitabine alone and GC in BTC patients. (8) Its outcome was similar to that of the ABC-02 study. From the results of these two clinical studies, GC therapy has been accepted as the standard therapy in Japan.…”

supporting

confidence: 66%

“…At the data cut-off point (April 2011; median follow-up time for all randomized patients, 10.6 months), four patients in the GS arm and one patient in the S-1 arm were still receiving the protocol treatment. Among the other patients, the median number of cycles of GS given was 10 (range, 1-34; interquartile range, [3][4][5][6][7][8][9][10][11][12][13][14] and that of S-1 was 3 (range, 1-9; interquartile range, 1-4). At the data cut-off point, 95% (96 ⁄ 101) of the patients terminated the protocol treatment.…”

Section: Resultsmentioning

confidence: 99%

“…(8,(14)(15)(16)(17) Another stratification factor used in this study was the clinical stage (II or III versus IV or recurrent). Locally advanced or metastatic cancer, the stratification factor used in the ABC-01 and ABC-02 studies, (7,18) has been shown to affect the OS of patients with advanced BTC.…”

Section: Gs S-1 Totalmentioning

confidence: 99%

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Randomized phase II study of gemcitabine plus S‐1 versus S‐1 in advanced biliary tract cancer: A Japan Clinical Oncology Group trial (JCOG 0805)

Morizane¹,

Okusaka²,

Mizusawa

et al. 2013

Cancer Science

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The oral fluoropyrimidine, S‐1, combined with or without gemcitabine is considered to be a promising agent for treating advanced biliary tract cancer; gemcitabine plus cisplatin is the current standard regimen. This randomized phase II trial was designed to evaluate the safety and efficacy of two regimens: gemcitabine plus S‐1 (GS) (gemcitabine: 1000 mg/m2, day 1 and day 8; S‐1: 60 mg/m2, twice daily on days 1–14, repeated every 3 weeks); and S‐1 (80 mg/m2, days 1–28, given orally twice daily for 4 weeks, followed by a 2‐week rest, repeated every 6 weeks). The regimen with a higher 1‐year survival would be selected for a subsequent phase III trial. Between February 2009 and April 2010, 101 patients were randomized. For the GS (n = 51) and S‐1 (n = 50) arms, the 1‐year survival was 52.9% (95% confidence interval, 38.5–65.5) and 40.0% (95% confidence interval, 26.5–53.1), and the median survival times were 12.5 and 9.0 months, respectively. Grade 3/4 hematological toxicities were more frequent in the GS arm (leucocytes 29.4%, neutrophils 60.8%, hemoglobin 11.8%, platelets 11.8%) than in the S‐1 arm (leucocytes 2.0%, neutrophils 4.0%, hemoglobin 4.0%, platelets 4.0%). Although two treatment‐related deaths occurred in the GS arm, all other grade 3/4 non‐hematological toxicities were reversible. In conclusion, GS was considered to be more promising and was selected as the test regimen for a subsequent phase III trial comparing GS with gemcitabine plus cisplatin combination therapy. This study was registered at the UMIN Clinical Trials Registry as UMIN 000001685 (http://www.umin.ac.jp/ctr/index.htm).

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confidence: 66%

Section: Resultsmentioning

confidence: 99%

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Randomized phase II study of gemcitabine plus S‐1 versus S‐1 in advanced biliary tract cancer: A Japan Clinical Oncology Group trial (JCOG 0805)

Morizane¹,

Okusaka²,

Mizusawa

et al. 2013

Cancer Science

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“…[26][27][28][29][30] For most of the patients, palliative therapeutic options exist and are based on multimodal promising combinations including systemic chemotherapy, endoscopic biliary stenting, radiation therapy and photodynamic treatment. 26,[31][32][33][34][35][36] Those palliative treatment options can help to improve survival, relieve symptoms and enhance the patient's quality of life. 37,38 The role of image-guided locoregional therapies in the management of patients with cancer has grown.…”

Section: Discussionmentioning

confidence: 99%

Transarterial chemoembolization in the treatment of patients with unresectable cholangiocarcinoma: Results and prognostic factors governing treatment success

Vogl

Naguib

Nour-Eldin

et al. 2011

Intl Journal of Cancer

125

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The aim of the study was to evaluate the effectiveness of transarterial chemoembolization (TACE) with four chemotherapeutic protocols in terms of local tumor control and survival of patients with unresectable cholangiocarcinoma (CCC) and to identify the prognostic factors governing treatment success. In the single-centre study, 115 patients (mean ages 5 60.4 years) with unresectable CCC were repeatedly treated with TACE. In total, 819 chemoembolization sessions were performed in 4 week intervals with a mean of 7.1 (range, 3-30) sessions per patient. The chemotherapeutic used was Mitomycin C only in 20.9% of patients, Gemcitabine only in 7%, Mitomycin C with Gemcitabine in 47% and combination of Gemcitabine, Mitomycin C and Cisplatin in 25.1%. Local tumor response was evaluated by MRI according to RECIST. Survival data were calculated according to the Kaplan-Meier method. Prognostic factors for patient's survival were evaluated using log-rank-test. The local tumor controls were: partial response 8.7%, stable disease 57.4% and progressive disease 33.9% of patients. The median and mean survival times from the start of TACE were 13 and 20.8 months. Survival rate from the start of TACE was 52% after 1-year, 29% after 2-years and 10% after 3-years. Initial tumor response, high tumor vascularity and Child-Pugh class A were statistically significant factors for patient's survival. No statistically significant difference between patients treated with different chemotherapy protocols was noted. In conclusion, TACE is a palliative and safe treatment option for patients with unresectable CCC. Child Pugh class B, tumor hypovascularity and initially progressive disease were poor prognostic factors for patient survival.Cholangiocarcinoma (CCC) is the second most common primary hepatic malignancy following hepatocellular carcinoma. 1 The tumor represents less than 2-3% of all cancers and up to 19% of primary liver cancers worldwide. [1][2][3][4] In Europe and North America, the average incidence of CCC is 1-2/100,000 per year. 5,6 The incidence during the last years is increasing, and this increasing incidence is associated with an increase in mortality. 2,7-10 Because of an advanced nature of the tumor on the time of first diagnosis, the therapeutic options for patients with unresectable CCC are limited.Transarterial chemoembolization (TACE) is a local, catheter-based, minimally invasive therapeutic option for unresectable liver tumors, and is defined as a selective administration of chemotherapy usually combined with embolization of the vascular supply of the tumor. 11 For patients with liver tumors, TACE, as a combination of local-arterial application of chemotherapeutic drugs with additional usage of embolization particles, is an effective and recommended treatment. The concept of TACE has been used in the management of patients with liver metastases from colorectal cancer, breast carcinoma as well as patients with unresectable hepatocellular carcinoma (HCC). [12][13][14][15][16][17] Regarding unresectable CCC there are few...

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“…Based on the results of phase II studies, the Japanese guideline for biliary tract and ampullary carcinomas recommends gemcitabine alone or S-1 alone as the first line chemotherapy [23]. Recently, randomized controlled trials comparing the combination of cisplatin plus gemcitabine with gemcitabine alone have shown the survival benefit of the former regimen (Table 1) [24,25]. Furthermore, a randomized controlled trial among best supportive care, fluorouracil plus folinic acid and gemcitabine plus oxaliplatin (Gemox) revealed improved survival with Gemox in patients with unresectable gallbladder cancer as compared with best supportive care and fluorouracil plus folinic acid (Table 2) [26].…”

Section: Introductionmentioning

confidence: 99%

Targeted therapy for biliary-tract cancer

Furuse

2010

The Lancet Oncology

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Abstract:It is necessary to establish effective chemotherapy to improve the survival of patients with biliary tract cancer, because most of these patients are unsuitable candidates for surgery, and even patients undergoing curative surgery often have recurrence. Recently, the combination of cisplatin plus gemcitabine was reported to show survival benefits over gemcitabine alone in randomized clinical trials conducted in the United Kingdom and Japan. Thus, the combination of cisplatin plus gemcitabine is now recognized as the standard therapy for unresectable biliary tract cancer. One of the next issues that need to be addressed is whether molecular targeted agents might also be effective against biliary tract cancer. Although some targeted agents have been investigated as monotherapy for first-line chemotherapy, none were found to exert satisfactory efficacy. On the other hand, monoclonal antibodies such as bevacizumab and cetuximab have also been investigated in combination with a gemcitabine-based regimen and have been demonstrated to show promising activity. Furthermore, clinical trials using new targeted agents for biliary tract cancer are also proposed. This cancer is a relatively rare and heterogeneous tumor consisting of cholangiocarcinoma and gallbladder carcinoma. Therefore, a large randomized clinical trial is necessary to confirm the efficacy of chemotherapy, and international collaboration is important.

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Gemcitabine alone or in combination with cisplatin in patients with biliary tract cancer: a comparative multicentre study in Japan

Cited by 618 publications

References 22 publications

Randomized phase II study of gemcitabine plus S‐1 versus S‐1 in advanced biliary tract cancer: A Japan Clinical Oncology Group trial (JCOG 0805)

Randomized phase II study of gemcitabine plus S‐1 versus S‐1 in advanced biliary tract cancer: A Japan Clinical Oncology Group trial (JCOG 0805)

Transarterial chemoembolization in the treatment of patients with unresectable cholangiocarcinoma: Results and prognostic factors governing treatment success

Targeted therapy for biliary-tract cancer

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