-
[show abstract]
[hide abstract]
ABSTRACT: Docetaxel is widely used as a chemotherapeutic agent for gastric cancer treatment. A combined regimen with sunitinib demonstrated a synergistic antitumour effect in a preclinical model. The aim of this study was to evaluate the efficacy and safety of this combination in patients with unresectable or metastatic advanced gastric cancer following failure of treatment with a fluoropyrimidine and platinum combination.
This open-label, phase II, randomised trial enrolled patients with unresectable or metastatic gastric cancer. Patients were assigned to either a docetaxel monotherapy arm (D only arm: 60 mg m(-2), every 3 weeks) or a combination arm (DS arm: docetaxel+sunitinib 37.5 mg every day). The primary end point of the study was time to progression and the secondary end points were overall response rate, disease control rate, overall survival, and toxicity profile. A pharmacokinetic study was also performed.
A total of 107 patients were entered into the study. The TTP was not significantly prolonged in the DS arm when compared with the D only arm (DS vs D only arm: 3.9 months (95% confidence interval (CI) 2.9-4.9) vs 2.6 months (95% CI 1.8-3.5) (P=0.206). The hazard ratio for TTP was 0.77 (95% CI 0.52-1.16). However, the objective response rate was significantly higher in the DS arm (41.1% vs 14.3%, P=0.002). Patients in the DS arm experienced stomatitis, diarrhoea, and hand-foot syndrome more frequently.
The addition of sunitinib to docetaxel did not significantly prolong TTP, although it significantly increased response.
British Journal of Cancer 03/2012; 106(9):1469-74. · 5.04 Impact Factor
-
J Lee,
T Lim,
J E Uhm,
K W Park,
S H Park,
S C Lee,
J O Park,
Y S Park,
H Y Lim,
T S Sohn,
J H Noh,
J S Heo,
C K Park,
S Kim,
W K Kang
[show abstract]
[hide abstract]
ABSTRACT: This study was to devise a prognostic model for metastatic gastric cancer patients undergoing first-line chemotherapy.
A retrospective analysis was carried out on 1455 gastric cancer patients, who received first-line chemotherapy from September 1994 to February 2005.
At multivariate level, poor prognostic factors were no previous gastrectomy [P = 0.003; relative risk (RR), 1.191; 95% confidence interval (CI) 1.061-1.338], albumin < 3.6 g/dl (P = or <0.001; RR, 1.245; 95% CI 1.106-1.402), alkaline phosphatase > 85 U/l (P = or <0.001; RR, 1.224; 95% CI 1.092-1.371), Eastern Cooperative Oncology Group performance status of two or more (P = or <0.001; RR, 1.690; 95% CI 1.458-1.959), the presence of bone metastases (P = 0.001; RR, 1.460; 95% CI 1.616-1.836), and the presence of ascites (P = or < 0.001; RR, 1.452; 95% CI 1.295-1.628). Of 1434 patients, 489 patients (34.1%) were categorized as low-risk group (zero to one factors), 889 patients (62.0%) as intermediate-risk group (two to four factors), and 56 patients (3.9%) as high-risk group (five to six factors). Median survival durations for low, intermediate, and high-risk groups were 12.5 months, 7.0 months, and 2.7 months, respectively.
This model should facilitate the individual patient risk stratification and thus, more appropriate therapies for each metastatic gastric cancer patient.
Annals of Oncology 06/2007; 18(5):886-91. · 6.43 Impact Factor
-
J Lee,
W K Kang,
J M Kwon,
S Y Oh,
H R Lee,
H J Kim,
B B Park,
H Y Lim,
M J Han,
J O Park,
Y S Park
[show abstract]
[hide abstract]
ABSTRACT: This nonrandomized open label phase II study evaluated the efficacy and safety of FOLFOXIRI in metastatic or recurrent gastric cancer patients.
Patients with histologically proven, metastatic gastric adenocarcinoma, aged 18-70 years, performance status zero to two, no prior chemotherapy, and with signed written informed consent were eligible. Treatment consisted of irinotecan 150 mg/m2 day 1, oxaliplatin 85 mg/m2 day 1, leucovorin 100 mg/m2 day 1, and 5-fluorouracil 2000 mg/m2 as a 48-h continuous infusion starting on day 1, which was repeated every 2 weeks.
From August 2004 to August 2005, 48 patients were prospectively enrolled. The median age was 54 years (24-69). In total, 386 cycles were administered with a median of nine cycles per patient (range 1-12 cycles) and 45 of 48 patients were assessable for treatment response. An independent review of tumor responses resulted in overall response rate of 66.7% (95% confidence interval=53.4% to 80.0%) by intent-to-treat analysis with one complete response and 31 partial responses. The median survival of all patients was 14.8 months and the median time to progression was 9.6 months. Most common grade 3/4 toxic effects were neutropenia (12% of all cycles) and emesis (8% of all cycles). Grade 2 peripheral neuropathy occurred in five patients. One (2%) patient had severe tumor bleeding and five (10%) patients experienced grade 3 diarrhea.
The modified FOLFOXIRI combination chemotherapy showed a very promising preliminary antitumor activity and was generally well tolerated as a first-line treatment of patients with metastatic gastric cancer.
Annals of Oncology 02/2007; 18(1):88-92. · 6.43 Impact Factor
-
B-B Park,
W S Kim, J Lee,
K W Park,
J-H Kang,
S-H Lee,
J O Park,
K Kim,
C W Jung,
Y S Park,
Y-H Im,
W K Kang,
Y-H Ko,
M H Lee,
K Park
[show abstract]
[hide abstract]
ABSTRACT: The present study aimed to analyse the treatment outcome of IMVP-16/Pd (ifosfamide, methotrexate, etoposide and prednisone) followed by high-dose chemotherapy and autologous stem cell transplantation (HDC/ASCT) for patients with peripheral T-cell lymphomas (PTCLs) who were previously treated with CHOP. Since 1995, 32 PTCL patients were treated with IMPV-16/Pd. Nine of 32 patients achieved a response (5 demonstrating complete response (CR) and 4 partial response), with an overall response rate of 28.1% (95% onfidence interval 0.12-0.45). Considering histopathologic subtypes, 3 of 4 relapsed natural killer (NK)/T-cell lymphoma patients (75%) achieved CR, but only 1 of 6 in non-NK/T-cell lymphoma patients (16.7%) achieved CR (P = 0.19). Six of 9 IMVP-16/Pd sensitive patients underwent HDC/ASCT. Three of them relapsed after 3, 4 and 15 months, respectively, of HDC/ASCT. Estimated 3-year overall survival and progression-free survival rates were 14.2% and 12.2%, respectively. Multivariate analysis revealed that responsiveness to first-line CHOP was a significant prognostic factor (P < 0.05). These results indicate that IMVP-16/Pd followed by HDC/ASCT appears to be an effective salvage regimen, especially for NK/T-cell lymphoma.
Leukemia and Lymphoma 12/2005; 46(12):1743-8. · 2.58 Impact Factor
-
S T Kim,
W K Kang,
J H Kang,
K W Park, J Lee,
S-H Lee,
J O Park,
K Kim,
W S Kim,
C W Jung,
Y S Park,
Y-H Im,
K Park
[show abstract]
[hide abstract]
ABSTRACT: We performed a phase II study of combination chemotherapy with irinotecan, 5-fluorouracil (5-FU) and leucovorin in metastatic gastric cancer patients who were previously treated with taxane and cisplatin, to evaluate the antitumour activity and toxicity of the combination chemotherapy. The metastatic gastric adenocarcinoma patients who were previously treated with taxane and cisplatin combination as first line, and had at least one measurable lesion, 0-2 ECOG performance status and adequate organ functions, were considered eligible. They received irinotecan (150 mg m(-2), day 1) and leucovorin (100 mg m(-2), day 1), followed by continuous infusion of 5-FU (1000 mg m(-2) day(-1), days 1 and 2) every 2 weeks. Treatment was continued until progression of disease was observed. In all, 64 patients were treated with this combination chemotherapy. The median age of the patients was 55 years (range, 33-74 years), and the median ECOG performance status was 1 (0-1, 61 (95%)). Out of 64 patients, 57 were assessable for response. Among 57 assessable patients, no complete response and 12 partial responses were observed (overall response rate, 21%; 95% confidence interval (CI), 10-32%). Stable disease was observed in 14 patients (25%) and progressive disease in 31 patients (54%). The median time to progression was 2.5 months (95% CI, 1.6-3.4) and the median overall survival since the start of the second-line modified FOLFIRI was 7.6 months (95% CI, 6.5-8.7). Grade 3-4 haematologic toxicities included neutropenia in seven patients (11%) and thrombocytopenia in five patients (8%). Grade 3-4 nonhaematologic toxicities included diarrhoea in two patients (3%) and vomiting in two patients (3%). There were no treatment-related deaths. The combination of irinotecan, 5-FU and leucovorin showed moderate activity and favourable toxicity profile as a second-line treatment in metastatic gastric cancer patients, who were previously treated with taxane and cisplatin.
British Journal of Cancer 06/2005; 92(10):1850-4. · 5.04 Impact Factor
-
J Lee,
W S Kim,
Y H Park,
S H Park,
K W Park,
J H Kang,
S S Lee,
S I Lee,
S-H Lee,
K Kim,
C W Jung,
Y C Ahn,
Y H Ko,
K Park
[show abstract]
[hide abstract]
ABSTRACT: Nasal-type NK/T cell lymphoma is an increasingly recognised disease entity of aggressive clinical behaviour. The objective of this study was to investigate clinical features and treatment outcomes in patients with nasal-type NK/T cell lymphoma. From January 1991 to December 2003, 26 patients diagnosed as nasal-type NK/T cell lymphoma were included in the analysis. One half of patients presented with poor performance status (ECOG > or =2); 46% of patients were categorised as high intermediate or high-risk group according to IPI; and 46% of patients were diagnosed at advanced stage. The median survival for 26 patients with nasal-type NK/T cell lymphoma was 7.4 months (95% CI, 0.1, 16.9). The treatment outcome of primary anthracycline-based chemotherapy was poor: 60% CR rate in localised disease and 0% CR rate in advanced disease. After a median follow-up of 24.4 months (range 3.1-99.0) in patients with localised disease who had achieved a CR (range 29.6-165.7), three patients (50.0%) developed disease recurrence at 6.1, 21.8, and 52.1 months, respectively, and all patients presented with locoregional failure. The predictive factors for poor survival were of age greater than 60, advanced stage and poor performance in multivariate analysis. In conclusion, Nasal-type NK/T cell lymphomas showed a poor response to the conventional anthracycline-based chemotherapy, and thus an investigation for an innovative therapy is urgently needed to improve survival in these patients.
British Journal of Cancer 04/2005; 92(7):1226-30. · 5.04 Impact Factor
-
S-H Lee, J Lee,
J Park,
S H Park,
K-E Lee,
S I Lee,
E Nam,
J O Park,
K Kim,
C W Jung,
Y S Park,
S S Yoon,
W K Kang,
M H Lee,
K Park,
Y-H Im
[show abstract]
[hide abstract]
ABSTRACT: The selection of chemotherapeutic regimens is challenging for metastatic breast cancer (MBC) patients whose diseases have failed to respond to anthracyline and taxane. Capecitabine has advantages of oral administration and favorable toxicity profiles. This study was conducted to evaluate the efficacy of capecitabine and to identify the subgroup of patients who would potentially have benefit from capecitabine monotherapy in patients with anthracycline- and taxane-pretreated MBC. Female patients with MBC who had been previously treated with anthracycline and taxane received oral capecitabine 2500 mg/m(2) divided in two doses daily for 2 wk with 1-wk rest period. Between September, 1999, and December, 2002, a total of 38 patients were enrolled. Among the 36 evaluable patients, one patient achieved a complete response (CR), 9 patients had partial responses (PRs), and 13 patients had stable diseases (SDs). Response rate was 26% [95% confidence interval (CI), 12-40%] and the tumor control rate (TCR, CR+PR+SD) was 61% (95% CI, 45-77%). The median follow-up duration was 27.8 mo. The median duration of response was 8.9 mo, the median time to progression was 4.6 mo, and the median overall survival was 18.1 mo. The major toxicities were hand-foot syndrome, diarrhea, and emesis. There was no treatment-related death. The predictors of better overall survival were positivity of hormone receptor, disease-free survival longer than 1 yr, non-refractoriness to anthracycline, and fewer number (<or= 3) of involved organs. Capecitabine monotherapy is effective and well tolerated for MBC patients who had previously been treated with anthracycline and taxane. The TCR could predict overall survival as well as the objective response in this study, suggesting a possible role of TCR as a surrogate marker for survival in MBC patients on salvage chemotherapy. The patients who have relatively slow growing tumor and less tumor burden could have benefit from capecitabine monotherapy following anthracycline- and taxane-based chemotherapy.
Medical Oncology 01/2004; 21(3):223-31. · 2.14 Impact Factor
-
[show abstract]
[hide abstract]
ABSTRACT: A pulsed dye laser is described in which a frequency is selected using a volume holographic transmission grating and a tuning mirror. We obtained a 20% energy conversion efficiency and a linewidth of 3 GHz at 560 nm.
Applied Optics 02/1991; 30(6):629-30. · 1.41 Impact Factor
