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1.
Emmanuel Mitry Pascal Hammel Gaël Deplanque Françoise Mornex Philippe Levy Jean-François Seitz Alain Moussy Jean-Pierre Kinet Olivier Hermine Philippe Rougier Eric Raymond 《Cancer chemotherapy and pharmacology》2010,66(2):395-403
Purpose
To evaluate the efficacy and safety of masitinib combined with gemcitabine in patients with advanced pancreatic cancer.Patients and methods
Twenty-two non-randomised patients with unresectable, locally advanced (n = 9) or metastatic pancreatic cancer (n = 13) received oral masitinib (9 mg/kg/day) combined with standard gemcitabine. All patients were na?ve to systemic chemotherapy or radiotherapy. The primary endpoint was time-to-progression (TTP) with efficacy and safety analyses performed on the intent-to-treat population. Secondary endpoints included overall survival (OS), as well as, subgroup analyses according to baseline disease, and performance status.Results
Overall median TTP was 6.4 months (95% CI [2.7–11.7]); 8.3 and 2.7 months, respectively, for locally advanced and metastatic patients; 6.4 and 0.8 months, respectively, for patients with KPS [80–100] or KPS [70]. Median OS was 7.1 months (95% CI [4.8–17.0]); 8.4 and 6.8 months for locally advanced or metastatic patients, respectively; 8.0 and 4.4 months in patients with KPS [80–100] or KPS [70], respectively. The 18-month observed survival rate was similar for locally advanced (22%) and metastatic patients (23%) and reached 28% for KPS [80–100] patients. The most common suspected adverse events were nausea, vomiting, rash, diarrhoea, peripheral oedema, anaemia, lymphopenia, thrombocytopenia, pyrexia, neutropenia, asthenia, leucopoenia, and abdominal pain, and most were of grades 1–2 severity.Conclusions
The efficacy and safety of masitinib combined with gemcitabine are encouraging, with extended survival and median TTP that support initiation of a phase 3 trial. 相似文献2.
Jhe-Cyuan Guo Shih-Hung Yang 《International journal of clinical oncology / Japan Society of Clinical Oncology》2014,19(4):634-642
Objective
The purpose of this study was to investigate the impact of combinational versus sequential gemcitabine and platinum on prognosis of advanced pancreatic cancer.Methods
Two hundred and three patients with advanced pancreatic cancer were selected. They were divided into GemP (first-line gemcitabine and platinum), Gem-then-P (sequential gemcitabine and platinum), Gem/other (first-line gemcitabine-based therapy without subsequent platinum), and Gem (first-line gemcitabine-based therapy without subsequent systemic therapy) groups. The Kaplan–Meier method and log-rank test were used for survival analyses. Cox regression model and propensity score matching were used for prognostic analyses.Results
The median survival was 12.5 months [95 % confidence interval (CI), 11.2–13.7] in the GemP group (N = 65), 8.3 months (95 % CI 5.0–11.7) in the Gem-then-P group (N = 35), 11.6 months (95 % CI 4.6–18.5) in the Gem/other group (N = 26), and 4.7 months (95 % CI 3.3–6.0) in the Gem group (N = 77) (P < 0.001). Considering the GemP and Gem-then-P groups, performance status, serum creatinine, and response to first-line treatment were independent prognostic factors for overall survival in the multivariate analysis. No specific factors were identified for predicting the choice between GemP and Gem-then-P.Conclusions
First-line gemcitabine and platinum-based combinations were not superior to sequential gemcitabine and platinum for overall survival. The best sequence of chemotherapy for advanced pancreatic cancer should be explored in future clinical trials. 相似文献3.
4.
In Gyu Hwang Hong Suk Song Myung Ah Lee Eun Mi Nam Joohan Lim Kyung Hee Lee Kyu Taek Lee Dae Young Zang Joung-Soon Jang 《Cancer chemotherapy and pharmacology》2014,74(6):1291-1296
Purpose
ABC-02 trial of gemcitabine plus cisplatin combination showed prolongation of overall survival in biliary tract cancer (BTC) patients. In this multicenter retrospective study, we evaluated the treatment outcome of gemcitabine combined with platinum (GP) compared to that of gemcitabine (G) alone in Korean BTC patients.Methods
One hundred and fifty-one patients with histologically confirmed biliary tract adenocarcinoma were enrolled at nine institutions between July 2003 and May 2011, including 100 treated with GP and 51 treated with G.Results
With a median follow-up of 7.7 months (range 0.4–38.3 months), the median overall survival (OS) was 12.4 months [95 % confidence interval (CI) 9.4–15.6 months] of the G group, which was not significantly different for the median OS of 11.0 months (95 % CI 9.7–12.3 months) of the GP group (p = 0.599). The median progression-free survival (PFS) was 3.9 months (95 % CI 0.8–7.0 months) in the G group and 3.3 months (95 % CI 2.6–4.0 months) in the GP group (p = 0.504). Overall response rates (ORR) were 18.8 % in G group and 23.9 % in GP group (p = 0.485).Conclusions
There was no significant difference in ORR, PFS, or OS for patients between the G group and the GP group, which was different from the ABC-02 trial. Therefore, gemcitabine monotherapy and GP combination are both effective regimens for Korean BTC patients. 相似文献5.
Naminatsu Takahara Hiroyuki Isayama Yousuke Nakai Takashi Sasaki Tsuyoshi Hamada Rie Uchino Suguru Mizuno Koji Miyabayashi Hirofumi Kogure Natsuyo Yamamoto Naoki Sasahira Kenji Hirano Hideaki Ijichi Keisuke Tateishi Minoru Tada Kazuhiko Koike 《Cancer chemotherapy and pharmacology》2013,72(5):985-990
Purpose
The aim of this study was to evaluate S-1 and oxaliplatin combination chemotherapy (SOX) in patients with refractory pancreatic cancer (PC).Methods
Consecutive patients with advanced PC refractory to gemcitabine who were treated with oral S-1 (80 mg/m2) on days 1–14 and intravenous oxaliplatin (100 mg/m2) on day 1 every 3 weeks were studied retrospectively. The primary end point was the objective response rate (ORR). The secondary end points were progression-free survival (PFS), overall survival (OS), the disease control rate (DCR), and safety.Results
Between March 2009 and October 2011, 30 patients were treated with SOX, with a median of two courses (range 1–8). The ORR and DCR were 10.0 and 50.0 %, respectively. Median PFS and OS were 3.4 months (95 % confidence interval [CI] 1.3–5.3) and 5.0 months (95 % CI 3.4–7.4), respectively. The median PFS and OS were 5.6 and 9.1 months in patients receiving S-1 and oxaliplatin as a second-line treatment. Major grade 3 or 4 adverse events included neutropenia (10.0 %), anemia (3.3 %), and diarrhea (6.7 %).Conclusions
SOX was well tolerated and moderately effective in patients with refractory PC. 相似文献6.
Johanna C. Bendell David S. Hong Howard A. Burris III Aung Naing Suzanne F. Jones Gerald Falchook Patricia Bricmont Agnes Elekes Edwin P. Rock Razelle Kurzrock 《Cancer chemotherapy and pharmacology》2014,73(1):125-130
Background
Statins have potential antineoplastic properties via arrest of cell-cycle progression and induction of apoptosis. A previous study demonstrated in vitro and in vivo antineoplastic synergism between statins and gemcitabine. The present randomized, double-blinded, phase II trial compared the efficacy and safety of gemcitabine plus simvastatin (GS) with those of gemcitabine plus placebo (GP) in patients with locally advanced and metastatic pancreatic cancer.Methods
Patients were randomly assigned to receive a 3-week regimen with GS (gemcitabine 1,000 mg/m2 on days 1, 8, and 15 plus simvastatin 40 mg once daily) or GP (gemcitabine 1,000 mg/m2 on days 1, 8, and 15 plus placebo). The primary end point was time to progression (TTP).Results
Between December 2008 and April 2012, 114 patients were enrolled. The median TTP was not significantly different between the two arms, being 2.4 months (95 % CI 0.7–4.1 months) and 3.6 months (95 % CI 3.1–4.1 months) in the GS and GP arms, respectively (P = 0.903). The overall disease control rate was 39.7 % (95 % CI 12.2–33.8 %) and 57.1 % (95 % CI 19.8–44.2 %) in the GS and GP arms, respectively (P = 0.09). The 1-year expected survival rates were similar (27.7 and 31.7 % in the GS and GP arms, respectively; P = 0.654). Occurrence of grade 3 or 4 adverse events was similar in both arms, and no patients had rhabdomyolysis.Conclusions
Adding low-dose simvastatin to gemcitabine in advanced pancreatic cancer does not provide clinical benefit, although it also does not result in increased toxicity. Given the emerging role of statins in overcoming resistance to anti-EGFR treatment, further studies are justified to evaluate the efficacy and safety of combined simvastatin and anti-EGFR agents, such as erlotinib or cetuximab, plus gemcitabine for treating advanced pancreatic cancer. 相似文献7.
Gyeong-Won Lee Hye Jung Kim Ji-Hyun Ju Seok-Hyun Kim Hoon Gu Kim Tae Hyo Kim Hyun Jin Kim Chi-Young Jeong Jung Hun Kang 《Cancer chemotherapy and pharmacology》2009,64(4):707-713
Background
We performed a phase II study of combination chemotherapy with S-1 plus gemcitabine for treating chemo-naïve patients with unresectable pancreatic cancer to evaluate the efficacy and toxicity.Patients and methods
Patients with histologically confirmed unresectable pancreatic cancer were eligible. The treatment consisted of S-1 (40 mg/m2 p.o. b.i.d. from D1 to 14) and gemcitabine (1,250 mg/m2 on D1 and 8), repeated every 3 weeks.Results
Thirty-two patients were enrolled between March 2005 and December 2007. No complete response was observed and a partial response was observed in 14 patients (44.0%), stable disease in eight patients (25.0%), and progressive disease in eight patients (25.0%). The median time to progression was 4.92 months (95% CI: 4.16–5.67 months), and the median overall survival was 7.89 months (95% CI: 5.96–9.82 months). The survival duration was significantly longer for the patients with a good performance status compared with that of the patients with a poor performance status. The major toxicities were grade 3–4 neutropenia (9, 28.1%), grade 3/4 thrombocytopenia (5, 15.6%), and grade 3 diarrhea (5, 15.6%).Conclusion
The combination chemotherapy of S-1 and gemcitabine showed promising antitumor activity and manageable toxicities, and especially for the good performance status patients with unresectable pancreatic cancer. 相似文献8.
Antonio Antón Agustí Barnadas Jesús Florián Nuria Ribelles María Lomas Juan Lao Ana González-Quintás Mireia Margelí Ana Belén Paules Javier Gayo Manuel Ramos 《Clinical & translational oncology》2011,13(4):281-286
Introduction
To assess the efficacy and safety profile of biweekly vinorelbine and tegafur/uracil (UFT) as treatment in patients with metastatic breast cancer previously treated with anthracyclines and taxanes.Patients and methods
Patients with histologically confirmed breast cancer, measurable disease, no more than one prior chemotherapy regimen for metastatic disease, an Eastern Cooperative Oncology Group (ECOG) performance status ≤2, and adequate bone marrow, renal and liver function were eligible. Patients received vinorelbine (30 mg/m2 on day 1) and UFT (250 mg/m2 daily) every two weeks for 12 cycles unless progression or unacceptable toxicity was observed.Results
Thirty-seven patients were included and received 311 cycles of chemotherapy. Efficacy and toxicity analyses were carried out on an intention-to-treat basis. The overall response rate was 35% (95% CI: 20–53). With a median follow-up of 18.6 months (95% CI: 1.0–74.3), the median time to progression was 7.0 months (96% CI: 5.2–8.9) and the median overall survival was 19.4 months (95% CI: 11.1–27.8). The most common severe toxicities were neutropenia (38% of patients) and asthenia (11% of patients).Conclusion
The combination of biweekly vinorelbine and UFT in patients with metastatic breast cancer pretreated with anthracyclines and taxanes is a well tolerated and effective regimen. AEMPS Trial Registration No.: 00-0534. 相似文献9.
Hiroki Yamaue Sohei Satoi Takamasa Kanbe Motoki Miyazawa Masaji Tani Manabu Kawai Seiko Hirono Kenichi Okada Hiroaki Yanagimoto A-Hon Kwon Tomoyuki Mukouyama Hiroaki Tsunoda Kazuo Chijiiwa Jiro Ohuchida Jun Kato Kazuki Ueda Taketo Yamaguchi Shinichi Egawa Kazuhiko Hayashi Tetsuhiko Shirasaka 《Cancer chemotherapy and pharmacology》2014,73(1):97-102
Purpose
Based on the results of first-line chemotherapy for advanced pancreatic cancer, S-1 was confirmed to be non-inferior to gemcitabine. However, the recommended regimen of 4 weeks of administration followed by 2 weeks of drug withdrawal frequently causes adverse effects. On the other hand, we experienced in clinical practice that alternate-day administration of S-1 reduced adverse effects and were tolerable for advanced pancreatic cancer patients unwilling to continue the standard daily administration. We therefore conducted a multicenter cooperative prospective study to compare daily with alternate-day administration of S-1 for advanced pancreatic cancer.Methods
Patients with advanced pancreatic cancer were eligible for enrollment in this trial. S-1 was administered at a dose of 40–60 mg twice daily, calculated according to body surface area, on Monday, Wednesday, Friday, and Sunday. Each treatment cycle was 42 days. The primary end point was overall survival (OS). Secondary end points were safety, response rate (RR), progression-free survival (PFS), and time to treatment failure (TTF).Results
Forty-eight patients were evaluable for response. OS as the primary end point was 8.4 months (95 % CI 5.4–10.8), and the 1-year survival rate was 29.2 %. PFS was 5.5 months, and TTF was 3.9 months. RR was 10.4 %, and the disease control rate was 79.2 %. Grade 3/4 hematological and non-hematological toxicities were minor. All of these adverse reactions were tolerable and reversible.Conclusions
The current data demonstrate the mitigation of adverse effects with alternate-day administration of S-1, and this appears to be a more sustainable option for advanced pancreatic cancer. 相似文献10.
David Goldstein M. Corona Gainford Chris Brown Niall Tebbutt Stephen P. Ackland Guy van Hazel Michael Jefford Ehtesham Abdi Sid Selva-Nayagam Val Gebski Danielle Miller Jenny Shannon 《Cancer chemotherapy and pharmacology》2011,67(3):519-525
Background
Biliary tract cancers (BTC) have a poor prognosis, and there is no consensus on the best chemotherapy regimen. This study determined the response rate for fixed-dose-rate (FDR) gemcitabine combined with cisplatin.Methods
This multicentre phase II trial enrolled 50 patients with inoperable locally advanced or metastatic BTC. Treatment consisted of FDR gemcitabine 1,000?mg/m2 (10?mg/m2/min) and cisplatin 20?mg/m2 on days 1 and 8 of a 21-day cycle. The primary endpoint was response rate. Secondary endpoints included safety, response duration (RD), progression-free (PFS) and overall survival (OS), and cancer antigen 19-9 response.Results
Thirteen patients (26%, 95% CI 14.6?C40.4) had a partial response, and 12 (24%) had stable disease. The median RD was 8.3?months (95% CI 6.91?C9.99); median PFS 4?months (95% CI 2.5?C6.77); and median OS 6.8?months (95% CI 5.0?C8.7). Treatment was well tolerated. Grade 3 and grade 4 nausea, vomiting, and fatigue were uncommon. Thirty-eight per cent of patients discontinued treatment because of toxicity, patient or clinician preference.Conclusions
This treatment combination had moderate activity with acceptable toxicity, supporting previous results that this combination has a role to play. The study does not suggest that FDR gemcitabine is superior to bolus infusion. 相似文献11.
Ji Soo Park Hei-Cheul Jeung Sun Young Rha Joong Bae Ahn Beodeul Kang Hong Jae Chon Min Hee Hong Seungtaek Lim Woo Ick Yang Chung Mo Nam Hyun Cheol Chung 《Cancer chemotherapy and pharmacology》2014,74(4):799-808
Purpose
We conducted a phase II study evaluating safety and efficacy of combination gemcitabine and capecitabine therapy for metastatic breast cancer patients following anthracycline and taxane treatment in Korea.Methods
This was a single-arm, non-randomized phase II study. Patients received 1,000 mg/m2 gemcitabine intravenously over 30 min on days 1 and 8, and 1,250 mg/m2 capecitabine orally twice daily on days 1–14 until disease progression or intolerable toxicity occurred. This regimen was repeated every 3 weeks. The primary outcome assessed was overall response rate [ORR, complete response (CR) + partial response (PR) as the best response], and secondary outcomes were progression-free survival (PFS), overall survival (OS), disease control rate (DCR) [maintenance of CR + PR + stable disease (SD) for at least 3 months], drug toxicity, and predictive factors for response to this regimen.Results
Of 41 patients, the ORR was 39.0 % (CR 0 %; PR 39.0 %), and DCR was 78.0 % using this chemotherapy. DCR for 6 and 12 months was 68.3 and 26.8 %, respectively. Median PFS was 10.0 months [95 % confidence interval (CI) 7.8–12.1], and median OS was 25.1 months (95 % CI 18.2–32.1). Prominent toxicities were neutropenia and hand–foot syndrome. Most adverse events were well known, relatively moderate, and reversible. Taxane sensitivity [odds ratio (OR) 0.169; 95 % CI 0.034–0.826; P = 0.028] and hepatic metastasis (OR 0.097; 95 % CI 0.017–0.559; P = 0.009) were significantly predictive of response to gemcitabine and capecitabine combination.Conclusions
This study showed reproducible anticancer activity and tolerable toxicity of gemcitabine and capecitabine combination therapy in recurrent or metastatic Korean breast cancer patients previously treated with anthracycline and taxane. 相似文献12.
Naminatsu Takahara Yousuke Nakai Hiroyuki Isayama Takashi Sasaki Yumiko Satoh Daiya Takai Tsuyoshi Hamada Rie Uchino Suguru Mizuno Koji Miyabayashi Dai Mohri Kazumichi Kawakubo Hirofumi Kogure Natsuyo Yamamoto Naoki Sasahira Kenji Hirano Hideaki Ijichi Minoru Tada Yutaka Yatomi Kazuhiko Koike 《Cancer chemotherapy and pharmacology》2013,71(1):85-92
Purpose
The aim of this study was to evaluate the efficacy and safety of irinotecan monotherapy in patients with advanced pancreatic cancer (APC).Methods
Patients with APC refractory to gemcitabine and S-1 were included. Irinotecan (100 mg/m2) was administered on days 1, 8, and 15 every 4 weeks until disease progression or unacceptable toxicity was observed. The relationship between uridine diphosphate glucuronosyl transferase 1 family polypeptide A1 gene (UGT1A1) polymorphisms and clinical outcomes was evaluated.Results
Between January 2007 and December 2011, 231 cycles were delivered in 56 patients. Irinotecan was administered as second-line chemotherapy in 35.7 % of patients and as third-line chemotherapy or later in 64.3 %. A partial response was achieved in two (3.6 %) and stable disease in 23 patients (41.0 %), giving a disease control rate of 44.6 %. The median time to progression (TTP) and overall survival (OS) were 2.9 (95 % confidence interval [CI] 1.8–3.5) months and 5.3 (95 % CI 4.5–6.8) months, respectively. Median survival from the first-line chemotherapy was 19.5 (95 % CI 15.3–23.8) months. Major grade 3/4 adverse events included neutropenia (28.6 %), anemia (12.5 %), and anorexia (10.7 %). Patients with *6 and/or *28 allele(s) (n = 15) were associated with grade 3/4 neutropenia and anorexia but showed longer TTP (5.3 vs. 1.8 months; p = 0.05), and OS (8.0 vs. 4.8 months; p = 0.09) than those without *6 and/or *28 (n = 29).Conclusions
Salvage chemotherapy with irinotecan was moderately effective and well-tolerated in patients with APC refractory to gemcitabine and S-1. UGT1A1 polymorphisms were associated with toxicity and efficacy. 相似文献13.
Hunho Song Boram Han Choong Kee Park Jong Hyeok Kim Jang Yong Jeon In-Gyu Kim Hyo Jung Kim Joo Young Jung Jung Han Kim Jung Hye Kwon Geundoo Jang Ho Young Kim Hyeong Su Kim Dae Ro Choi Dae Young Zang 《Cancer chemotherapy and pharmacology》2013,72(4):845-852
Purpose
To evaluate the efficacy and safety of combined gemcitabine and S-1 as first-line chemotherapy for patients with locally advanced or metastatic pancreatic cancer.Methods
This study included patients who had been diagnosed with unresectable, locally advanced or metastatic adenocarcinoma arising from the pancreas, which was histologically or cytologically confirmed and involved at least 1 unidimensionally measurable lesion. The regimen consisted of intravenous 1,000 mg/m2 gemcitabine on day 1 and 8 combined with oral S-1 on days 1–14 every 21 days. The dosage of S-1 was based on the body surface area (BSA) as follows: 40 mg bid (total 80 mg/day) for a BSA of <1.25, 50 mg bid (total 100 mg/day) for a BSA of ≥1.25 but <1.5, and 60 mg bid (total 120 mg/day) for a BSA of ≥1.5. Treatment consisted of at least 2 courses unless rapid disease progression was noted. The primary end points were the response and disease control rates, and the secondary end points were toxicity and survival.Results
Thirty-seven patients were enrolled between August 2005 and December 2010. The median number of chemotherapy cycles was 4 (range 1–28 cycles). Response to treatment could be evaluated in 31 patients. None of the patients showed complete response, but 5 achieved partial response. The response rate was thus 13.5 % [95 % confidence interval (CI) 2.7–24.3 %] in the intent-to-treat population. Sixteen patients (43.2 %; 95 % CI 27–59.5 %) showed stable disease, and the overall disease control rate was 56.8 % (95 % CI 40.6–72.9 %). For all 37 patients, the median progression-free survival was 4.6 months (95 % CI 1.8–7.6 month), and the median overall survival was 9.4 month (95 % CI 5.8–12.6 month). Chemotherapy-related grade 3/4 hematological toxicities were neutropenia (36.1 %), leucopenia (22.2 %), and anemia (13.9 %). The non-hematological toxicities were generally mild.Conclusions
Combination chemotherapy with gemcitabine and S-1 was effective, convenient, and safe in patients with advanced pancreatic cancer. 相似文献14.
Koo DH Ryu MH Ryoo BY Lee SS Moon JH Chang HM Lee JL Kim TW Kang YK 《Gastric cancer》2012,15(3):305-312
Background
Doses and schedules of the combination of S-1 and cisplatin for the treatment of advanced gastric cancer (AGC) have not been standardized. We therefore evaluated the efficacy and feasibility of a 3-week schedule of S-1 and cisplatin in patients with AGC, as well as assessing factors prognostic of patient outcomes.Methods
A total of 159 patients with AGC were treated with S-1 (40?mg/m2 bid on days?1–14) and cisplatin (60?mg/m2 IV on day?1) between January 2004 and December 2008.Results
Median follow-up duration was 20.0?months (range, 11.4–48.5?months), during which time 129 patients (81.1%) died. Patients received a median 6 cycles of chemotherapy (range, 1–19 cycles). Among the 59 patients with measurable disease, 1 achieved a complete response (1.7%) and 24 (40.7%) had partial responses, giving an overall response rate of 42.4% (95% CI, 23.0–61.8%). The median progression-free survival (PFS) was 5.8?months (95% CI, 4.8–6.9?months), and the median overall survival (OS) was 11.3?months (95% CI, 9.6–13.0?months). Multivariate analysis showed that initial metastasis, bone metastasis, and liver metastasis were independent prognostic factors for reduced PFS, whereas poor performance status, initial metastasis, and bone metastasis were prognostic for reduced OS. Application of a previous prognostic model showed that observed PFS and OS survival curves for patients in various risk groups differed significantly (P?0.001 each).Conclusions
A 3-week regimen of S-1 plus cisplatin was active and well tolerated as first-line treatment in patients with AGC. Disease status and bone metastasis were the most important prognostic factors. 相似文献15.
Keun-Wook Lee Yu Jung Kim Kyung-Hun Lee Sae-Won Han Tae-Yong Kim Do-Youn Oh Seock-Ah Im Tae-You Kim Yung-Jue Bang In Sil Choi Jee Hyun Kim 《Cancer chemotherapy and pharmacology》2014,74(3):447-455
Purpose
To investigate the efficacy of gemcitabine plus uracil–tegafur (UFT) combination chemotherapy as a salvage treatment in patients with metastatic colorectal cancer (MCRC).Methods
This single-arm phase II study was conducted at three institutions in Korea. Patients with MCRC refractory to fluoropyrimidine, oxaliplatin and irinotecan were enrolled. Gemcitabine 800 mg/m2 was administered intravenously on days 1, 8 and 15. UFT 200 mg/m2/day was taken orally in three divided doses on days 1–21. Cycles were repeated every 4 weeks, and tumor evaluation was carried out every 8 weeks. The primary endpoint of this study was 8-week progression-free survival (PFS) rate.Results
Forty-one patients were enrolled. Fourteen patients received gemcitabine/UFT as a third-line treatment and 37 patients as a fourth-line or later-line therapy. Toxicities were easily manageable, and non-hematologic toxicities of ≥grade 3 were rare. The most common toxicity of ≥grade 3 was neutropenia (20.0 %). One patient showed partial response (response rate, 2.4 %) and 14 (34.1 %) showed stable disease. The 8-week PFS rate was 42.3 %. The median PFS was 1.7 months [95 % confidence interval (CI) 1.6–1.8 months], and the median overall survival was 9.2 months (95 % CI 5.8–12.6 months).Conclusions
Overall efficacy of gemcitabine/UFT in refractory MCRC was unsatisfactory. However, we could find a minor proportion of patients who showed prolonged tumor stabilization to gemcitabine/UFT. Further studies are warranted to identify a patient subgroup that might have benefits from gemcitabine/UFT therapy. 相似文献16.
Do-Youn Oh Yongjun Cha In-Sil Choi So-Young Yoon In Keun Choi Jee Hyun Kim Sang Cheul Oh Chang Duck Kim Jae Sun Kim Yung-Jue Bang Yeul Hong Kim 《Cancer chemotherapy and pharmacology》2010,65(3):527-536
Purpose
To confirm the efficacy and toxicity of gemcitabine and S-1 combination chemotherapy when used as a first-line therapy in patients with unresectable pancreatic cancer.Methods
Patients with locally advanced or metastatic or recurrent pancreatic adenocarcinoma, which was histologically or cytologically proven, with at least one measurable lesion were eligible for the study. Gemcitabine at a dose of 1,000 mg/m2 was intravenously given over 30 min on days 1 and 8, while S-1 at a dose of 40 mg/m2 was orally given twice daily from day 1 to 14, and the cycle was repeated every 3 weeks. The objective response rate, which was assessed according to RECIST criteria, was the primary end point.Results
A total of 38 patients were enrolled between June 2006 and June 2007. The median number of treatment courses was 5.5 (range 1–22). Thirty-four patients were evaluable for response. Although no complete response was seen, partial responses were achieved in 11 patients, resulting in an overall response rate of 32% [95% confidence interval (CI) 17–48%]. The median response duration was 6.0 months (95% CI 4.6–8.3 months), the median time-to-progression was 5.4 months (95% CI 2.9–8.0 months), and the median overall survival was 8.4 months (95% CI 5.7–11.1 months). The major grade 3/4 hematologic toxicities were neutropenia (39.5%), leukopenia (15.8%), thrombocytopenia (2.6%), and anemia (7.9%). The major grade 3/4 non-hematologic toxicities included anorexia (10.5%), stomatitis (2.6%), rash (7.9%), fatigue (7.9%) and hyperbilirubinemia (5.3%).Conclusions
Gemcitabine and S-1 combination chemotherapy was effective and tolerable in patients with unresectable pancreatic cancer. 相似文献17.
O. Juan J. Vidal R. Gisbert J. Muñoz S. Maciá J. Gómez-Codina 《Clinical & translational oncology》2014,16(7):637-643
Purpose
To evaluate the association in the change of circulating tumor cell (CTC) levels and clinical outcomes (PFS and OS) in patients with advanced non-small cell lung cancer (NSCLC) treated homogenously with docetaxel and gemcitabine administered every 2 weeks.Methods
We prospectively evaluated 37 patients for CTC levels at baseline and after 2 months of chemotherapy (before third cycle). Detection was carried out with the CellSearch system.Results
Nine of the 37 patients (24 %) had ≥2 CTCs at the baseline determination. Median progression-free survival (PFS) was 4.3 months (95 % CI 2.5–8.3) for patients with CTC 0–1 as compared to 9.4 months (95 % CI 1.2–12.2) for those with CTC ≥2 (p = 0.3506). Median overall survival (OS) was 8.1 (95 % CI 2.8–16.3) and 12.2 (95 % CI 1.4–12.2) months for patients with 0–1 CTCs and ≥2 CTCs, respectively (p = 0.7639). Patients with a second CTC quantification were classified as: group 1, CTC = 0–1 at baseline and CTC = 0–1 after second chemotherapy cycle (18 patients); group 2, CTC ≥2 at baseline and CTC = 0–1 after second determination (5 patients). Median PFS was 7.7 and 9.9 months for group 1 and group 2, respectively (p = 0.4467).Conclusions
CTCs ≥2 at baseline were detected only in 24 % of this group of patients with advanced NSCLC and poor performance status. No significant differences in PFS and OS between patients with or without CTCs at baseline were observed. 相似文献18.
V. Georgoulias S. Apostolaki V. Bozionelou E. Politaki M. Perraki N. Georgoulia K. Kalbakis A. Kotsakis A. Xyrafas S. Agelaki D. Mavroudis 《Cancer chemotherapy and pharmacology》2014,73(6):1217-1225
Purpose
The incidence of lung cancer in patients with interstitial lung disease (ILD) is higher than in the general population; however, the clinical benefit of chemotherapy and the appropriate regimen for non-small-cell lung cancer (NSCLC) patients with ILD remain unclear. This study was conducted to elucidate the safety and efficacy of palliative chemotherapy with gemcitabine or pemetrexed, both in combination with a platinum agent in NSCLC patients with ILD.Patients and methods
Patients with advanced or recurrent NSCLC and ILD who received gemcitabine or pemetrexed in combination with a platinum agent as first-line chemotherapy were retrospectively analyzed. Clinical outcomes, including response rate, overall survival (OS), and progression-free survival (PFS), in addition to the acute exacerbation of ILD after chemotherapy were investigated.Results
Between January 2007 and December 2011, 52 patients were analyzed. The median age at chemotherapy was 67. Thirty-two patients (61.5 %) had adenocarcinoma histology. With respect to the types of ILD, idiopathic interstitial pneumonia (IIP) and non-IIP were observed in 42 (80.8 %) and 10 (19.2 %) patients, respectively. The FEV1 level was less than 80 % of the predicted value in 15 of the 41 patients in whom it was measured. The overall response rate was 42.3 % (95 % CI 28.8–55.9), and the median PFS was 5.4 months (95 % CI 4.6–6.2). The median OS was 7.9 months (95 % CI 5.5–10.3), and the 1-year survival rate was 31.7 % (95 % CI 19.0–44.4). Eight patients (15.4 %) died within 3 months of first-line chemotherapy. Multivariate analysis demonstrated that a heavy smoking history (40 or more pack-year smoking history) was an independent adverse prognostic factor for OS. An acute exacerbation of ILD (AE-ILD) caused by first-line chemotherapy was noted in 5.8 % of patients.Conclusion
Our results suggest that gemcitabine or pemetrexed in combination with platinum agents could be a feasible option for advanced NSCLC with ILD with some risk of AE-ILD or early death. To establish the efficacy of palliative chemotherapy for patients with NSCLC and ILD, further well-controlled prospective studies are needed. 相似文献19.
Hui-Ju Ch’ang Chin-Lun Huang Hsiu-Po Wang Her-Shyong Shiah Ming-Chu Chang Chang-Ming Jan Jen-Shi Chen Yu-Wen Tien Tsann-Long Hwang Jaw-Town Lin Ann-Lii Cheng Jacqueline Whang-Peng Li-Tzong Chen 《Cancer chemotherapy and pharmacology》2009,64(6):1173-1179
Purpose
To evaluate the efficacy and safety profile of a triplet regimen consisting of gemcitabine, oxaliplatin, and infusional fluorouracil and leucovorin (LV) in advanced pancreatic carcinoma (APC).Patients and methods
Chemotherapy-naïve patients with histo-/cytologically proven unresectable APC, and bi-dimensionally measurable diseases were eligible. Treatment consisted of fixed-dose rate (10 mg/m2/min) infusion of 800 mg/m2 gemcitabine followed by 2-h infusion of 85 mg/m2 oxaliplatin and then 48-h infusion of fluorouracil and LV (3,000 and 300 mg/m2, respectively) every 2 weeks (the GOFL regimen). The primary end-point was objective response rate.Results
Forty-five patients were enrolled and received a median of seven [95% confidence interval (CI) 6.4–8.8] cycles of treatment. On intent-to-treat analysis, the overall response and disease-control rates were 33.3% (95% CI 21.4–48.0%) and 68.9% (95% CI 54.8–83.0%), respectively. Clinical benefit response was observed in 46.2% of initially symptomatic patients. The median time-to-tumor progression and overall survival were 5.1 (95% CI 4.0–6.3) months and 8.7 (95% CI, 6.1–11.3) months, respectively. Major grade 3–4 toxicities were neutropenia (28.9%, with 4.4% complicated with fever), peripheral sensory neuropathy (15.6%), nausea/vomiting (13.3%), and diarrhea (6.7%).Conclusions
The triplet regimen is feasible and exhibits promising activity against APC, deserving further exploration. 相似文献20.
Kentaro Sudo Takeshi Ishihara Nobuto Hirata Fumiaki Ozawa Tadashi Ohshima Ryosaku Azemoto Kenji Shimura Takeshi Nihei Takayoshi Nishino Akihiko Nakagawa Kazuyoshi Nakamura Taro Hara Motohisa Tada Rintaro Mikata Katsunobu Tawada Osamu Yokosuka So Nakaji Taketo Yamaguchi 《Cancer chemotherapy and pharmacology》2014,73(2):389-396