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1.
Tsuruta H Inoue T Narita S Horikawa Y Saito M Obara T Numakura K Maita S Satoh S Tsuchiya N Habuchi T 《International journal of clinical oncology / Japan Society of Clinical Oncology》2011,16(5):533-538
Background
To evaluate the efficacy and toxicity of a combination chemotherapy consisting of gemcitabine, carboplatin, and docetaxel (GCD) in patients with advanced urothelial carcinoma (UC) as a phase II trial.Materials and methods
Patients with metastatic or locally advanced unresectable UC were eligible for this trial. All enrolled patients were considered to be “unfit??for cisplatin-based chemotherapy, or to have methotrexate, vinblastine, doxorubicin, cisplatin (MVAC)-refractory UC. The chemotherapy regimen consisted of gemcitabine 1000?mg/m2 on days 1 and 8, and carboplatin (with a target area under the curve of 5) and docetaxel 70?mg/m2 on day 1; this was repeated every 21?days.Results
Thirty-five patients were enrolled, with a median age of 68?years. A total of 89 cycles were administered (median, 2 cycles). Major toxicities were Grade 3/4 neutropenia in 28 (80.0%) patients and Grade 3/4 thrombocytopenia in 18 (51.5%). An objective response rate (ORR) was 11 of 21 patients (52.4%), including a complete response in 1 (4.8%). The median overall survival (OS) was 13.1?months (1-year survival rate, 60%) and the median progression-free survival (PFS) was 5.0?months. Among 16 patients who had previously received MVAC, the ORR, the median PFS, the median OS and 1-year survival rate was 56.3%, 5.0?months, 12.6?months and 54%, respectively.Conclusions
GCD chemotherapy is active and well tolerated as a first- or second-line therapy for patients with advanced UC. Response rate, duration and survival did not differ between those with and without a history of MVAC treatment. 相似文献2.
3.
Matteo Dalla Chiesa Gianluca Tomasello Sebastiano Buti Rodrigo Kraft Rovere Matteo Brighenti Silvia Lazzarelli Gianvito Donati Rodolfo Passalacqua 《Cancer chemotherapy and pharmacology》2011,67(1):41-48
Purpose
To evaluate a new strategy of two sequential, intensified chemotherapy regimens in metastatic gastric cancer.Patients and methods
Chemo-na?ve patients with metastatic gastric cancer were enrolled to receive 4 cycles of TCF-dd (docetaxel initially 85?mg/m2 and cisplatin initially 75?mg/m2 on day 1 [later modified due to toxicity: 70 and 60?mg/m2 respectively], l-folinic acid 100?mg/m2 on days 1 and 2, 5-fluorouracil 400?mg/m2 bolus and then 600?mg/m2 as a 22?h continuous infusion on day 1 and 2, every 14?days). Subsequently, patients with CR, PR or SD received 4 cycles of COFFI (oxaliplatin 85?mg/m2, irinotecan 140?mg/m2, l-folinic acid 200?mg/m2, 5-fluorouracil bolus 400?mg/m2 on day 1 followed by 2,400?mg/m2 as a 48?h continuous infusion, every 14?days). In both regimens pegfilgrastim 6?mg subcutaneously on day 3 was included.Results
Forty consecutive patients were enrolled. TCF-dd regimen achieved an ORR of 55% (95% CI, 40?C70). Twenty-three patients proceeded to COFFI. After this regimen the ORR was then increased to 60% (95% CI, 45?C75). Among the 21 patients treated with TCF-dd after the protocol amendments, main grade 3?C4 toxicities were: neutropenia (29%), thrombocytopenia (19%), asthenia (24%) and diarrhea (14%). COFFI caused grade 3?C4 neutropenia (all not febrile) and diarrhea in 35% and 17% of patients respectively.Conclusions
A sequential strategy with TCF-dd followed by COFFI is very active and may be of special interest in selected patients. 相似文献4.
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5.
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6.
Ozaka M Matsumura Y Ishii H Omuro Y Itoi T Mouri H Hanada K Kimura Y Maetani I Okabe Y Tani M Ikeda T Hijioka S Watanabe R Ohoka S Hirose Y Suyama M Egawa N Sofuni A Ikari T Nakajima T 《Cancer chemotherapy and pharmacology》2012,69(5):1197-1204
Purpose
To evaluate the efficacy and safety of the combination of gemcitabine (GEM) and S-1 (GS) in comparison to GEM alone (G) for unresectable pancreatic cancer.Methods
In this multicenter randomized phase II study, we randomly assigned unresectable pancreatic cancer patients to either the GS group or the G group. The GS group regimen consists of intravenous 1,000?mg/m2 GEM during 30?min on days 1 and 8, combined with 80?mg/m2 oral S-1 twice daily on days 1–14, repeated every 3?weeks. On the other hand, the G group regimen consists of intravenous 1,000?mg/m2 GEM on days 1, 8, and 15, repeated every 4?weeks. The primary endpoint was objective response rate (ORR). Secondary end points included treatment toxicity, clinical response benefit, progression-free survival (PFS), and overall survival.Results
We registered 117 patients from 16 institutions between June 2007 and August, 2010. The ORR of the GS group was 28.3%, whereas that of the G group was 6.8%. This difference was statistically significant (P?=?0.005). The disease control rate was 64.2% in the GS group and 44.1% in the G group. Median PFS was 6.15?months in the GS group and 3.78?month in the G group. This was also statistically significant (P?=?0.0007). Moreover, the median overall survival (OS) of the GS group was significantly longer than that of the G group (13.7?months vs. 8.0?months; P?=?0.035). The major grade 3–4 adverse events were neutropenia (54.7% in the GS group and 22.0% in the G group), thrombocytopenia (15.1% in the GS group and 5.1% in the G group), and skin rash (9.4% in the GS group).Conclusions
The GS group showed stronger anticancer activity than the G group, suggesting the need for a large randomized phase III study to confirm GS advantages in a specific subset. 相似文献7.
Nishikawa K Morita S Matsui T Kobayashi M Takeuchi Y Takahashi I Sato S Miyashita Y Tsuburaya A Sakamoto J Kakeji Y Baba H 《Gastric cancer》2012,15(4):363-369
Background
The purpose of this study was twofold: (1) to compare S-1 with infusional 5-fluorouracil (FU) to determine which would be a better partner of paclitaxel (PTX), and (2) to compare a concurrent strategy with a sequential one, the latter strategy being the one that is widely used in Japanese general practice.Methods
The 161 eligible patients were randomized into four arms to receive the following regimens: A (sequential), intravenous 5-FU at 800?mg/m2 for 5?days every 4?weeks followed by weekly PTX at 80?mg/m2; B (sequential), S-1 at 80?mg/m2 for 4?weeks and 2-week rest followed by PTX; C (concurrent), intravenous 5-FU at 600?mg/m2 for 5?days and weekly PTX at 80?mg/m2 every 4?weeks; and D (concurrent), S-1 for 14?days and PTX at 50?mg/m2 on days 1 and 8 every 3?weeks. The primary endpoint was the overall survival (OS) rate at 10?months.Results
The ten-month OS rates in arms A, B, C, and D were 63, 65, 61, and 73%, respectively. The OS was best in the concurrent S-1/PTX arm, with a mean survival time of 15.4?months, but no significant difference was observed between the four arms. Response rates were higher in the concurrent arms than in the sequential arms.Conclusion
Our study did not show sufficient prolongation of survival with the concurrent strategy to proceed to a phase-III trial; however, the sequential arms showed survival comparable to that in the concurrent arms, with less toxicity. In patients who are ineligible for cisplatin (CDDP), sequential treatment starting with S-1 and proceeding to PTX would be a good alternative strategy, considering quality of life (QOL) and the cost-benefits of an oral agent as first-line treatment. 相似文献8.
Ourania Katopodis Aris Polyzos Nikolaos Kentepozidis Stylianos Giassas Maria Rovithi Vasiliki Bozionelou Kostas Kalbakis Lambros Vamvakas Dimitris Mavroudis Vassilis Georgoulias 《Cancer chemotherapy and pharmacology》2011,67(2):361-368
Purpose
To investigate the efficacy and toxicity of the docetaxel and capecitabine combination in patients with previously treated, unresectable adenocarcinoma of the pancreas.Patients and Methods
Patients with pancreatic adenocarcinoma, pre-treated with gemcitabine-based chemotherapy, were treated with capecitabine (800?mg/m2 orally, twice a day for 14?days) and docetaxel (75?mg/m2 i.v, on day1), every 3?weeks. The primary end-point was overall response rate (RR).Results
Thirty-one patients were enrolled in the study; 93.6% of them had a performance status (PS) of 0?C1 and 96.8% had stage IV disease. Patients received a median of 4 cycles/patient, and the main reason for treatment discontinuation was disease progression. Partial response was observed in three (9.7%) patients, stable disease in seven (22.6%) (disease control rate: 32.3%, 95% CI: 15.80?C48.71%) and disease progression in 21 (67.6%). The median progression-free survival (PFS) was 2.4?months (95% CI: 1.6?C3.13) and the median overall survival (OS) was 6.3?months (95% CI: 3.38?C9.23); the estimated 1-year survival rate was 14.7%. Grade III/IV neutropenia occurred in 10 (32.2%) patients and febrile neutropenia in one patient. Other severe non-hematologic toxicities were mild and manageable. After 2 chemotherapy cycles, pain control occurred in 20% of patients and stabilization of body weight in 40%.Conclusion
The combination of docetaxel/capecitabine may confer good disease control associated with improvement of quality of life as second-line chemotherapy in patients with metastatic pancreatic cancer. 相似文献9.
T. Waddell S. Gollins W. Soe J. Valle J. Allen D. Bentley J. Morris A. Lloyd R. Swindell M. B. Taylor M. P. Saunders 《Cancer chemotherapy and pharmacology》2011,67(5):1111-1117
Purpose
To evaluate the efficacy, safety and quality of life of a short course of oxaliplatin plus capecitabine (XELOX) followed by single-agent capecitabine in patients with previously untreated, inoperable, metastatic colorectal cancer.Methods
Patients received intravenous oxaliplatin 130?mg/m2 on d1 plus oral capecitabine 1,000?mg/m2 twice daily (bid) on d1?C14 every 21?days for four cycles. Patients achieving stable disease (SD) or better than received capecitabine 1,250?mg/m2 bid on d1?C14 every 21?days until disease progression. The primary endpoint was progression-free survival (PFS).Results
Overall, 21/45 (47%) of patients responded to the initial XELOX chemotherapy whilst SD or better was documented in 76%. Median PFS was 6.7 (95% CI 5.7?C9.6) months, and median overall survival (OS) was 20.5 (95% CI 13.1?C28.1) months. In the 34 patients who then received capecitabine maintenance therapy, the median PFS was 8.1 (95% CI 6.2?C11.8) months and median OS was 23.1 (95% CI 17.8?C28.5) months. A marked reduction in the vast majority of all grades of adverse event occurred on switching from initial XELOX to maintenance capecitabine chemotherapy including grades 1?C2 (77 vs. 47%) and grade 3 (7 vs. 3%) neuropathy, diarrhoea and lethargy.Conclusions
Short-course XELOX followed by capecitabine maintenance therapy provides an active and well-tolerated treatment option for patients with previously untreated metastatic colorectal cancer. A median OS of more than 20?months is promising and by limiting the number of oxaliplatin infusions, this approach minimises the risk of unwanted cumulative neurotoxicity, is cheaper and more convenient for both patients and healthcare providers. 相似文献10.
Xue Meng Jianhua Wang Xindong Sun Lvhua Wang Ming Ye Pingbo Feng Guangying Zhu You Lu Chun Han Shuchai Zhu Zhongxing Liao Jinming Yu 《Radiotherapy and oncology》2013
Background and purpose
This multicenter phase II trial investigated cetuximab combined with chemoradiotherapy in patients with esophageal squamous cell carcinoma (ESCC).Material and methods
Eligible patients with non-resectable, locally-advanced ESCC received cetuximab 400 mg/m2 loading dose on day 1; and on day 1 of the 2nd–7th weeks: cetuximab 250 mg/m2, paclitaxel 45 mg/m2, and cisplatin 20 mg/m2, concurrent with 59.4 Gy/33 fractions of radiation therapy. Primary endpoint was clinical response rate. Secondary endpoints included overall survival (OS), progression-free survival (PFS), safety, and KRAS status.Results
Of 55 patients enrolled, 45 completed therapy. Forty-four patients had a clinical response: 29 complete response and 15 partial response. One-year PFS and OS of 45 evaluable patients were 84.23% and 93.33%, respectively, and 2-year PFS and OS were 74.87% and 80.00%, respectively. Non-hematologic adverse events were generally grade 1 or 2; primarily rash (92.7%), mucositis (45.5%), fatigue (41.8%), and nausea (38.2%). Grade 3 hematologic adverse events included neutropenia (32.7%) and anemia (1.8%). No KRAS mutations were identified in 50 evaluated samples.Conclusions
Cetuximab can be safely administered with chemoradiotherapy to patients with locally-advanced ESCC and may improve clinical response rate. 相似文献11.
Eun Joo Kang Seock-Ah Im Do-Youn Oh Sae-Won Han Jin-Soo Kim In Sil Choi Jin Won Kim Yu Jung Kim Jee Hyun Kim Tae-You Kim Jong Seok Lee Yung-Jue Bang Keun-Wook Lee 《Gastric cancer》2013,16(4):581-589
Background
The aim of this study was to evaluate the activity and safety of the combination chemotherapy of 5-fluorouracil (5-FU), leucovorin, and irinotecan (FOLFIRI regimen) after failure of fluoropyrimidine, platinum, and taxane in gastric cancer (GC) and to evaluate the prognostic factors for survival.Methods
Patients received biweekly FOLFIRI chemotherapy as third-line treatment. The FOLFIRI-1 consisted of irinotecan (180 mg/m2 in a 2-h infusion) on day 1, and then leucovorin (200 mg/m2 in a 2-h infusion) and 5-FU (a 400 mg/m2 bolus, followed by 600 mg/m2 in a 22-h continuous infusion) on days 1 and 2. FOLFIRI-2 consisted of irinotecan (180 mg/m2 in a 2-h infusion) on day 1, and then leucovorin (400 mg/m2 in a 2-h infusion) and 5-FU (a 400 mg/m2 bolus, followed by 2400 mg/m2 in a 46-h continuous infusion) on day 1.Results
A total of 158 patients were included. The overall response rate was 9.6 % in patients with measurable lesions. The median progression-free survival (PFS) and overall survival (OS) were 2.1 months [95 % confidence interval (CI), 1.7–2.5] and 5.6 months (95 % CI, 4.7–6.5), respectively. The major grade 3/4 toxicity was myelosuppression (36.7 %). Good performance status (PS), fewer metastatic sites, and longer duration from the first-line to third-line chemotherapy were independent prognostic factors affecting both PFS and OS.Conclusions
The FOLFIRI regimen showed antitumor activity and tolerable toxicity profiles against advanced GC in the third-line setting. Patients with good PS, fewer metastatic sites and longer previous treatment duration might have the maximal benefit from third-line chemotherapy. 相似文献12.
Background
A chemotherapy regimen with oxaliplatin, fluorouracil, and leucovorin is commonly used to treat advanced gastric cancer (AGC). This study was designed to compare the efficacy and the safety of oxaliplatin plus fluorouracil/leucovorin administered biweekly (mFOLFOX6) between elderly patients aged over 65?years and younger counterparts with AGC.Methods
This analysis included 82 AGC patients (≥65:31, <65:51). Patients with previously untreated chemo-na?ve advanced adenocarcinoma of the stomach received oxaliplatin 85?mg/m2, 5-FU bolus 400?mg/m2 on day?1 and 5-FU 1,500?mg/m2, leucovorin 75?mg/m2 22?h infusion on days?1 and 2 every 2?weeks. The aim of the study was to compare efficacy and safety, including response rate (RR), progression-free survival (PFS), overall survival, and grade ≥3 adverse events, between patients aged ≥65 years and patients aged <65 years.Results
Median progression-free survival (PFS) was not significantly different between both groups (≥65: 5.8?months, <65: 5.7?months, respectively, HR 0.77, 95% CI: 0.44–1.16, P?=?0.18). Median overall survival was not significantly different between both groups (≥65: 10.3?months, <65: 9.5?months HR 0.83, 95% CI: 0.50–1.37, P?=?0.46). The rate of grade 3 or 4 neutropenia did not differ with age group (≥65: 51.6%, <65: 43.1%); nor did the rates of neutropenic fever (≥65: 16.1%, <65: 5.9%), and infection without neutropenia (≥65: 3.2%, <65: 3.9%). Rates of grade ≥3 toxicities such as thrombocytopenia, nausea/vomiting, or peripheral neuropathy were not significantly different between the two groups.Conclusions
mFOLFOX6 maintains its efficacy and safety in elderly patients aged over 65?years in comparison with AGC patients aged <65 years. Its judicious use should be considered regardless of age. 相似文献13.
Chow LQ Blais N Jonker DJ Laurie SA Diab SG Canil C McWilliam M Thall A Ruiz-Garcia A Zhang K Tye L Chao RC Camidge DR 《Cancer chemotherapy and pharmacology》2012,69(3):709-722
Purpose
The primary objective of this phase I dose-escalation study was to identify the maximum tolerated dose (MTD) of sunitinib plus pemetrexed in patients with advanced cancer.Methods
Using a 3?+?3 dose-escalation design, patients received oral sunitinib qd by continuous daily dosing (CDD schedule; 37.5 or 50?mg) or 2?weeks on/1?week off treatment schedule (Schedule 2/1; 50?mg). Pemetrexed (300?C500?mg/m2 IV) was administered q3w. At the proposed recommended phase 2 dose (RP2D), additional patients with non-small cell lung cancer (NSCLC) were enrolled.Results
Thirty-five patients were enrolled on the CDD schedule and seven on Schedule 2/1. MTDs were sunitinib 37.5?mg/day (CDD/RP2D) or 50?mg/day (Schedule 2/1) with pemetrexed 500?mg/m2. Dose-limiting toxicities included grade (G) 5 cerebral hemorrhage, G3 febrile neutropenia, and G3 anorexia. Common G3/4 drug-related non-hematologic adverse events (AEs) at the CDD MTD included fatigue, anorexia, and hand?Cfoot syndrome. G3/4 hematologic AEs included lymphopenia, neutropenia, and thrombocytopenia. No significant drug?Cdrug interactions were identified. Five (24%) NSCLC patients had partial responses.Conclusions
In patients with advanced solid malignancies, the MTD of sunitinib plus 500?mg/m2 pemetrexed was 37.5?mg/day (CDD schedule) or 50?mg/day (Schedule 2/1). The CDD schedule MTD was tolerable and demonstrated promising clinical benefit in NSCLC. 相似文献14.
Lobna R. Ezz Elarab Manal M. Abdel Wahab Menha Swellam Zakaria Mostafa 《中德临床肿瘤学杂志》2010,9(10):569-573
Objective
The aim of our study was to evaluate the response and tolerability to treatment when using gemcitabine-cisplatin combination (GC), followed by maintenance therapy of oral etoposide for non-progressive patients in trial to improve progression free survival and overall survival.Methods
Thirty nine patients with extensive small cell lung cancer (SCLC) and ECOG ≤ 2 received 4 cycles of chemotherapy consisting of gemcitabine 1000 mg/m2 (day 1 and 8) cisplating 75 mg/m2 (day 1) every three weeks. Twenty seven non-progressive patients after 4 cycles of chemotherapy were randomized either to receive oral etoposide 50 mg/m2 for consecutive 15 days every 3 weeks vs no therapy for three months or progression.Results
Thirty nine eligible patients treated with GC, 27 non progressive patients were subsequently randomized to oral etoposide or observation. Median follow-up was 18 months. The overall response rate to GC was 59% and toxicity to oral etoposide was mild. There was improvement in median progression-free survival (PFS) favoring the maintenance arm of 10.5 months vs 7 months (P < 0.05). Median overall survival (OS) had improved towards the maintenance arm (13 vs 11.5 months). One year survival (60% vs 24%), 18 months survival (20% vs 5%) favoring the maintenance. Multivariate analysis revealed that age, performance status, maintenance therapy, and response to treatment were independent prognostic factors for OS. Age, maintenance therapy, and response to treatment were highly significant factors for PFS.Conclusion
Gemcitabine-cisplatin is an effective and tolerable regiment for extensive disease of SCLC. The addition of 3 months of oral etoposide in non progressing patients was associated with a significant improvement of PFS and longer OS. 相似文献15.
Daruka Mahadevan MD PhD Joseph M. Unger PhC Catherine M. Spier MD Daniel O. Persky MD Fay Young MD Michael LeBlanc PhD Richard I. Fisher MD Thomas P. Miller MD 《Cancer》2013,119(2):371-379
BACKGROUND:
Patients with peripheral T‐cell lymphomas (PTCLs) have inferior progression‐free survival (PFS) and overall survival (OS) compared with patients who have aggressive B‐cell non‐Hodgkin lymphoma. Because PTCLs over express multidrug resistance gene 1/P‐glycoprotein (MDR‐1/P‐gp), we devised platinum, etoposide, gemcitabine, and methylprednisolone (PEGS) with agents that are not substrates of the efflux pump. Gemcitabine was included because of its excellent single‐agent activity in PTCL.METHODS:
Patients who had PTCL with stage II bulky disease, stage III or IV disease with extra‐nodal, nodal, and transformed cutaneous presentations were eligible. Patients received intravenous cisplatin 25 mg/m2 on days 1 through 4, etoposide 40 mg/m2 on days 1 through 4, gemcitabine 1000 mg/m2 on day 1, and methylprednisolone 250 mg on days 1 through 4 of a 21‐day cycle for 6 cycles.RESULTS:
In total, 34 patients were enrolled, 33 were eligible, and 79% were newly diagnosed. Histologic types were PTCL not otherwise specified (n = 15), anaplastic lymphoma kinase (ALK)‐negative anaplastic large cell lymphoma (n = 4), angioimmunoblastic T‐cell lymphoma (n = 6), or other T‐cell non‐Hodgkin lymphomas (n = 8). Adverse events included 1 grade 5 infection with grade 3 or 4 neutropenia and 9 grade 4 hematologic toxicities. The overall response rate was 39% (47% in PTCL not otherwise specified, 33% in angioimmunoblastic T‐cell lymphoma, 25% in ALK‐negative and 38% in other T‐cell non‐Hodgkin lymphomas). The PFS rate at 2 years was 12% (95% confidence interval, 0.1%‐31%), and the median PFS was 7 months. The OS rate at 2 years was 30% (95% confidence interval, 8%‐54%), and the median OS was 17 months. Immunohistochemical analysis of P‐gp expression revealed strong positivity in a subset of lymphoma cells (n = 6) and tumor endothelium (n = 25).CONCLUSIONS:
Overall, PEGS was well tolerated, but OS was not considered promising given the design‐specified targets. These results may serve as a benchmark for future comparisons for non‐CHOP regimens. Cancer 2013. © 2012 American Cancer Society. 相似文献16.
Fogelman D Jafari M Varadhachary GR Xiong H Bullock S Ozer H Lin E Morris J Cunningham P Bennett B Abbruzzese JL Wolff RA 《Cancer chemotherapy and pharmacology》2011,68(6):1431-1438
Purpose
The gemcitabine and oxaliplatin (GEMOX) has yielded among the longest progression-free survival durations in patients with advanced pancreatic cancer (APC). We postulated that adding bevacizumab would increase the effectiveness of GEMOX.Methods
Eligible patients had stage III or IV pancreatic cancer, ECOG PS 0-2, and no prior gemcitabine. Treatment included 1,000?mg/m2 intravenous gemcitabine over 100?min on day 1, 10?mg/kg intravenous bevacizumab on day 1, and 100?mg/m2 oxaliplatin given on day 2. Cycles were repeated every 2?weeks. CT imaging was performed every 6?weeks.Results
Fifty patients were enrolled: 14 had stage III disease, the remainder stage IV. Median age was 59?years. Fourty-five patients were ECOG 0-1. The grade 3?C4 toxicity rate was 94%; fatigue (47%) and nausea (40%) were frequent. One patient died after a bowel perforation; a second died of a CVA. The median PFS was 4.9?months; median survival was 11.9?months; 1?year survival was 42%. Locally advanced patients lived 12.8?months; metastatic patients lived 10.2?months. Patients developing grade 3 hypertension were more likely to have a radiologic response (P?=?.012); survival among the top and bottom quintiles of hypertension was 14.7 and 6.2?months, respectively. Survival correlated with baseline CA 19?C9 (P?=?.004) and radiologic response. The overall response rate was 36%; 34% demonstrated stable disease.Conclusions
The GEMOX/bevacizumab regimen demonstrated an excellent median overall survival but did not meet our objective of a 14?month median survival. Toxicity was significant. We do not recommend further evaluation of this regimen. 相似文献17.
Wada M Yamamoto M Ryuge S Nagashima Y Hayashi N Maki S Otani S Katono K Takakura A Yanaihara T Igawa S Yokoba M Mitsufuji H Kubota M Katagiri M Masuda N 《Cancer chemotherapy and pharmacology》2012,69(4):1005-1011
Background
In this phase II clinical trial, we evaluated the efficacy and safety of S-1 monotherapy in patients with previously treated advanced non-small-cell lung cancer (NSCLC). We also measured plasma concentrations of 5-fluorouracil (5-FU) and 5-chloro-2,4-dihydroxypyridine components of S-1 and examined correlation with effectiveness and toxicity.Methods
S-1 was given orally at a dose of 80?mg/m2/day for 14 consecutive days, followed by a 7-day rest period. This treatment course was repeated until disease progression or intolerable toxicity.Results
We enrolled 30 patients. The response rate was 26.7% (8/30), and the disease control rate was 70% (21/30). Median progression-free survival (PFS) was 3.1?months, and median overall survival (OS) was 11.2?months. Mutations in the epidermal growth factor receptor (EGFR) gene were analyzed in 27 patients. The response rate was higher in patients with mutant EGFR (50.0%) than in those with wild-type EGFR (11.8%, P?=?0.0288). Median PFS was 4.8 and 2.5?months (P?=?0.038), and median OS was 22.4 and 8.4?months (P?=?0.071). There was no grade 4 toxicity in this study. Five patients had grade 3 non-hematologic toxicity, and there was a trend toward higher plasma concentrations of 5-FU in those patients than in another patients.Conclusions
S-1 monotherapy is effective and well-tolerated treatment for previously treated advanced NSCLC. 相似文献18.
Mitsugu Kochi Yuji Akiyama Tatsuya Aoki Ken Hagiwara Takao Takahashi Katsuji Hironaka Futoshi Teranishi Fumihiko Osuka Masahiro Takeuchi Masashi Fujii Toshifusa Nakajima 《Cancer chemotherapy and pharmacology》2013,72(5):1097-1102
Purpose
The purpose of this multicenter phase II study was to evaluate the efficacy and safety of a combination of irinotecan, 5-fluorouracil (5-FU), and leucovorin (FOLFIRI) plus bevacizumab as first-line chemotherapy in Japanese patients with metastatic colorectal cancer.Methods
Patients with metastatic colorectal cancer were eligible for enrollment. On day 1 of a 14-day cycle, patients received bevacizumab 5 mg/kg, irinotecan 150 mg/m2, and l-leucovorin 200 mg/m2 as an intravenous infusion, followed by 5-FU 400 mg/m2 as an intravenous bolus and then 5-FU 2,400 mg/m2 as an 46-h intravenous infusion. This treatment cycle was repeated. The primary endpoint was progression-free survival (PFS).Results
We enrolled 40 patients, but one withdrew consent before starting treatment. The remaining 39 patients received a total of 509 cycles of FOLFIRI plus bevacizumab (median 11 per patient; range 1–30). The median PFS was 11.5 months, the median overall survival (OS) was 22.0 months, and the 1-year OS rate was 81.8 %. All 39 patients had adverse events. Grade 3 or 4 neutropenia and stomatitis occurred in 21 (53.9 %) and 4 (10.3 %) patients, respectively.Conclusion
Our results suggest that FOLFIRI plus bevacizumab is a clinically effective regimen with a manageable toxicity profile as first-line chemotherapy in patients with metastatic colorectal cancer. 相似文献19.
Koizumi W Nakayama N Tanabe S Sasaki T Higuchi K Nishimura K Takagi S Azuma M Ae T Ishido K Nakatani K Naruke A Katada C 《Cancer chemotherapy and pharmacology》2012,69(2):407-413
Purpose
We conducted a phase II study to evaluate the efficacy and safety of a triplet regimen of docetaxel, cisplatin, and S-1 in patients with unresectable or recurrent gastric cancer.Methods
Docetaxel (40?mg/m2) and cisplatin (70 or 60?mg/m2) were given on day 1 of a 28-day cycle. S-1 (40?mg/m2) was given twice daily on days 1?C14. Treatment with this regimen was continued for a maximum of 6 cycles. Subsequently, patients with no disease progression received a combination of docetaxel and S-1.Results
Fifty-nine patients were enrolled. The median number of administered cycles was 8 (range, 1?C25). Because some patients had serious myelosuppression and renal dysfunction with 70?mg/m2 of cisplatin, dose of cisplatin was reduced to 60?mg/m2 after 19 patients had been treated. Common severe toxic effects of grade 3 or 4 were leukocytopenia (44%), neutropenia (72%), anemia (15%), and febrile neutropenia (14%). The overall response rate of this group was 81% (95% confidence interval (CI), 71?C91%). The median overall survival and progression-free survival were 18.5 (95% CI, 15.6?C21.5) and 8.7 (95% CI, 6.7?C10.7) months, respectively.Conclusions
Triplet of docetaxel, cisplatin, and S-1 is a well-tolerated and highly active regimen for advanced or recurrent gastric cancer. A 60?mg/m2 of cisplatin is as effective as 70?mg/m2 of cisplatin. 相似文献20.
Yoshimoto M Takao S Hirata M Okamoto Y Yamashita S Kawaguchi Y Takami M Furusawa H Morita S Abe C Sakamoto J 《Cancer chemotherapy and pharmacology》2012,70(2):331-338