Mark H Lee

Konkuk University Medical Center, Changnyeong, South Gyeongsang, South Korea

Are you Mark H Lee?

Claim your profile

Publications (26)75.16 Total impact

  • [Show abstract] [Hide abstract]
    ABSTRACT: We studied the efficacy of two different doses of ganciclovir to prevent cytomegalovirus (CMV) disease in allogeneic hematopoietic stem cell transplantation (HSCT) recipients. We randomly assigned allogeneic HSCT recipients who had CMV infection to receive preemptive ganciclovir therapy with or without induction phase (5 mg/kg twice daily for 1 week). Thirty-two and thirty-six patients were randomized to the standard and the low-dose therapy group, respectively. The median time to CMV antigenemia or viremia clearance was 7 days (3-25 days) in the standard therapy group versus 11 days (3-69 days) in the low-dose therapy group (P = 0.540). The incidence of CMV disease was similar between the two groups (P = 0.366). The Kaplan-Meier estimate of event-free survival by day 180 after HSCT was 76.2% in the standard therapy group versus 66.7% in the low-dose therapy group (P = 0.590). Severe neutropenia (<0.5 x 10(9)/L) was observed in four (12.5%) patients in the standard therapy group versus two (5.6%) patients in the low-dose therapy group (P = 0.314). This study suggests that a low-dose ganciclovir preemptive therapy can be as effective as the standard-dose ganciclovir preemptive therapy for the prevention of CMV disease in allogeneic HSCT recipients.
    International journal of hematology 06/2010; 91(5):886-91. · 1.17 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: Purpose: L-ascorbic acid (LAA) modifies the in vitro growth of leukemic cells from approximately 50% of patients with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS). To test the hypothesis that depletion of LAA, alternating with supplementation to prevent scurvy, would provide therapeutic benefit, a single-arm pilot trial was conducted (ClinicalTrials.gov identifier: NCT00329498). Experimental results: During depletion phase, patients with refractory AML or MDS were placed on a diet deficient in LAA; during supplementation phase, patients received daily intravenous administration of LAA. An in vitro assay was performed pretherapy for LAA sensitivity of leukemic cells from individual patients. Results: Of 18 patients enrolled, eight of 16 evaluable patients demonstrated a clinical response. Responses were obtained during depletion (four patients) as well as during supplementation (five patients) but at a pharmacologic plasma level achievable only with intravenous administration. Of nine patients for whom the in vitro assay indicated their leukemic cells were sensitive to LAA, seven exhibited a clinical response; compared with none of six patients who were insensitive to LAA. Conclusions: The clinical benefit, along with a conspicuous absence of significant adverse events, suggests that further testing of LAA depletion alternating with pharmacologic dose intravenous supplementation in patients with these and other malignancies is warranted.
    European Journal Of Haematology 04/2009; 83(2):108-18. · 2.55 Impact Factor
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: We analyzed the efficacy and toxicity of a modified Cancer and Leukemia Group B (CALGB) 19802 regimen in adult acute lymphoblastic leukemia (ALL). From February 2002 to August 2005, 25 adults with untreated ALL were enrolled in the study. Compared to the original regimen, the modified CALGB 19802 regimen consisted of a 4-drug induction (cyclophosphamide, daunorubicin, vincristine, and prednisone) instead of a 5-drug induction (L-asparaginase was added to the previous regimen). This was followed by high-dose methotrexate (1,000 mg/m(2) x 3 days) and cytarabine (2,000 mg/m(2) x 4 days) for the consolidation cycles. High-dose systemic and intrathecal methotrexate was given for central nervous system prophylaxis. Twenty-three patients (92%) achieved a complete remission (CR), and two patients (8%) had refractory disease. With a median follow-up of 21.5 months, 10 patients (40%) were alive and continued to be in CR. The 3-yr probability of an event-free survival and the overall survival were 39.0% and 47.4%, respectively. Treatment related mortality and major grade 3 to 4 neurotoxicity occurred in 1 patient and 3 patients, respectively. The modified CALGB 19802 regimen demonstrated a high remission rate and a favorable survival rate.
    Journal of Korean Medical Science 05/2008; 23(2):278-83. · 1.25 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: Korea is an endemic area for hepatitis B virus (HBV) infection. Reactivation of HBV is a well-recognized complication in patients with chronic HBV infection undergoing cytotoxic or immunosuppressive therapy, and there are some reports of hepatitis B reverse seroconversion after HSCT. This study evaluated changes in HBV serology after HSCT. We reviewed the medical records of 141 patients who had available HBV serologic data after autologous HSCT. Patient information was retrospectively collected from the BMT database. Before transplantation, 12 patients were positive for hepatitis B surface antigen (HBsAg) and received lamivudine prophylaxis. There was 1 case of reactivation of HBV among these patients. One hundred twenty-nine patients were negative for HBsAg before HSCT, of whom 110 were positive and 19 were negative for hepatitis B surface antibody (anti-HBs). Sixty-two of the 110 patients who were positive for anti-HBs were also positive for hepatitis B core antibody (anti-HBc). Eight patients were negative for anti-HBs and anti-HBc. Seven patients who were initially negative for HBsAg were identified as positive after HSCT, and 5 of those 7 patients developed acute hepatitis, thus indicating reverse seroconversion. Univariate analysis showed that reverse seroconversions were observed more frequently with multiple myeloma than another disease (P = .005; relative risk, 11.854; 95% confidence interval, 1.381-101.770). Other factors, such as age, sex, and presence of HBcAb before HSCT, had no statistically significant affect on reverse seroconversion. In conclusion, reverse seroconversion of HBV is not a rare complication of autologous HSCT, and the risk of reverse seroconversion after treatment is a serious concern due to possible complications arising from patients' suppressed immune systems.
    Biology of Blood and Marrow Transplantation 05/2007; 13(4):463-8. · 3.94 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: The purpose of this study was to define distinctive clinical features of "nasal" and "nasal-type" NK/T cell lymphomas by assessing prognostic factors. The anatomic definition of extranasal NK/T cell lymphoma has been vague resulting in variable definitions of extranasal sites by different groups. We analysed the clinical behavior of 90 NK/T cell lymphoma patients and attempted to elucidate the prognostic factors for risk-based stratification of therapy. We observed no significant difference between "nasal" and "nasal-type" NK/T cell lymphomas in regards to clinical features and survival using the conventional anatomic classification. We suggest the categorisation of the two subtypes of NK/T cell lymphoma as follows: UNKTL (upper aerodigestive tract NK/T cell lymphoma) including all lymphomas confined to nasal cavity, nasopharynx, and the upper aerodigestive tract and EUNKTL (extra-upper aerodigestive tract NK/T cell lymphoma) group to include all sites other than the UNKTL group. The EUNKTL group in this study had advanced stage at diagnosis, higher LDH, higher IPI score, poorer performance and inferior response to the anthracycline-based chemotherapy with statistical significance. There was a significant difference in survival rate between EUNKTL and UNKTL group (20.0%, 54.0%, respectively, P = 0.0068). More aggressive treatment should be sought for this particular group of patients for EUNKTL patients.
    European Journal of Cancer 08/2005; 41(10):1402-8. · 5.06 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: Although several studies have investigated factors influencing peripheral blood stem cell (PBSC) mobilization in patients with nonmyeloid malignancies in an effort to increase the efficiency of autologous PBSC transplantation (APBSCT), there are very few reports on the efficiency of PBSC mobilization in patients with leukemia. We analyzed the effects of influential variables on successful mobilization and the correlation between infused cell doses and engraftment in acute myeloid leukemia (AML) patients in first complete remission (CR1) who received APBSCT. Between May 1998 and May 2003, 34 patients with AML underwent APBSC collections at our institution. All patients were in CR1 at the time of transplantation. Except for 1 patient, all patients successfully achieved the target CD34(+) cell yield of > or = 2 x 10(6)/kg. Among progenitor cells, the CD34(+) cell dose and the colony-forming unit-granulocyte-macrophage count showed significant correlations with neutrophil and platelet engraftments. The time to neutrophil engraftment was inversely correlated to the number of infused CD34(+) cells (r = -0.67; P < .001), whereas the time to neutrophil engraftment was not significantly correlated with the number of monocytes (r = 0.20; P = .701) or the number of nucleated cells (r = 0.35; P = .062). The time to platelet engraftment was significantly correlated with the dose of infused CD34(+) cells (r = -0.47; P = .012). The univariate analysis showed that more CD34(+) cells per kilogram and more CD34(+) cells per kilogram per day were collected from patients who had a shorter interval (less than 2 months) between diagnosis and PBSC harvest (P = .0111). In conclusion, this study showed that the CD34(+) cell dose was most strongly correlated with a successful engraftment in AML CR1 patients who underwent APBSCT. The proper timing of PBSC collections should be explored to optimize the outcome of APBSCT in AML CR1 patients.
    International Journal of Hematology 04/2005; 81(3):258-63. · 1.68 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: Allogeneic stem cell transplantation (ASCT) has improved the outcome of acute myelogenous leukemia (AML). To further improve the treatment outcome of ASCT in AML, finding a modifiable prognostic factor is mandatory. We evaluated the effect of CD34(+) cell dose on survival in allogeneic bone marrow transplantation (BMT) from HLA-matched sibling donors for AML patients in first complete remission (CR1). The 99 patients included in our analysis were classified into high CD34(+) cell dose group (CD34(+) cells > or = 2.5 x 10(6)/kg) and low CD34(+) cell dose group (CD34(+) cells < 2.5 x 10(6)/kg). The high CD34(+) cell dose patients had better overall survival (5-year overall survival rate, 75% +/- 6% vs 52% +/- 9%; P = .01) and leukemia-free survival (5-year leukemia-free survival rate, 70% +/- 6% vs 44% +/- 9%; P = .04). CD34(+) cell dose was the only independent prognostic factor in overall survival and leukemia-free survival. The high CD34(+) cell dose group had a lower relapse incidence with a borderline statistical significance (5-year relapse rate, 27% +/- 6% vs 50% +/- 10%; P = .09). There were no differences in the engraftment of neutrophil and platelet, grade II-IV acute graft-versus-host disease (GVHD), extensive-stage chronic GVHD, and transplant-related mortality between the high and low CD34(+) cell dose groups. We confirmed that high CD34(+) cell dose favorably affects the outcomes in allogeneic BMT for AML. The effort to attain a high CD34(+) cell dose should be pursued during bone marrow harvest in allogeneic BMT for AML in CR1.
    Biology of Blood and Marrow Transplantation 03/2005; 11(2):122-8. · 3.94 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: The outcome of systemic chemotherapy in metastatic hepatocellular carcinoma (HCC) patients had been disappointing. Based on the demonstrated antitumor activities and different mechanisms of action and toxicity profiles, we designed a phase II trial of combination therapy with doxorubicin and cisplatin in metastatic HCC patients anticipating a synergistic interaction of the combination. From January 1998 to January 2003, 42 consecutive patients with metastatic HCC were accrued. The regimen consisted of doxorubicin 60 mg/m2 delivered as an intravenous infusion over 30 min on day 1, followed by cisplatin 60 mg/m2 infused over 1 h on day 1. The cycle was repeated every 28 days. The objective tumor response was evaluated after two or three courses of chemotherapy. The serum alpha-fetoprotein level was measured at the start of every cycle. In total, 122 cycles of the regimen were administered, with a median of three cycles per patient (range one to eight cycles). The median age of the patients was 45 years (range 19-61 years), and 37 were evaluable for treatment response. The objective response rate was 18.9% (95% CI 8.0-35%) with one complete response and six partial responses. Six patients (16.2%) had stable disease and 24 patients (64.9%) had progression. Median overall survival of 37 patients was 7.3 months (95% CI 5.9-8.6 months). The median time to progression of all evaluable patients was 6.6 months (95% CI 5.4-7.8 months). Of 37 evaluable patients, 12 32.4%, 95% CI 18.0-49.8%) showed more than 50% decrease in AFP level from their baseline AFP and the median time to decrease in AFP by more than 50% was 1.8 months with a range of 0.7-4.7 months. The chemotherapy was well tolerated and the most common grade 3/4 side effects were neutropenia (14.3%), thrombocytopenia (11.9%), and diarrhea (9.5%). Combination chemotherapy with doxorubicin and cisplatin in metastatic HCC patients showed modest antitumor activity with relatively tolerable adverse effects. The objective response rate of the regimen was comparable to those found in other phase II trials, but the search for the optimal chemotherapy should be continued.
    Cancer Chemotherapy and Pharmacology 12/2004; 54(5):385-90. · 2.80 Impact Factor
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: There is increasing evidence that L-ascorbic acid (LAA) is selectively toxic to some types of cancer cells at pharmacological concentrations, functioning as a pro-oxidant rather than as an anti-oxidant. However, the molecular mechanisms by which LAA initiates cellular signaling leading to cell death are still unclear. In an effort to gain insight into these mechanisms, the effects of LAA on eukaryotic transcription nuclear factor NF-kappaB and cyclooxygenase-2 (COX-2) expression were investigated. In the present study, LAA suppressed DNA binding activity of NF-kappaB, composed of a p65/p50 heterodimer, through inhibition of degradation of inhibitory kappaB-alpha (IkappaB-alpha) and prevention of nuclear translocation of p65. The inhibitory effect of LAA on NF-kappaB activity was dependent upon glutathione levels in HL-60 cells, as well as generation of H2O2 but not superoxide anion. LAA also downregulated the expression of COX-2, which has a NF-kappaB binding site on its promoter, through repressing NF-kappaB DNA binding activity. Moreover, cotreatment of 1 microM arsenic trioxide (As2O3) with various concentrations of LAA enhanced an LAA-induced repression of NF-kappaB activity and COX-2 expression. In conclusion, our data suggest that LAA exerts its anti-tumor activity through downregulation of NF-kappaB activity and COX-2 expression, and these inhibitory effects can be enhanced by co-treatment with As2O3.
    Journal of Cellular Biochemistry 11/2004; 93(2):257-70. · 3.06 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: The purpose of this study was to determine the activity and safety of docetaxel plus cisplatin as second-line chemotherapy for advanced gastric cancer. This trial included patients who had failed first-line chemotherapy with a 5-fluorouracil regimen within 1 year before their enrollment. After registration, patients were treated with docetaxel intravenously at a dose of 60 mg/m2 given over 1 hour followed by cisplatin 60 mg/m2 given over 2 hours. The treatment was continued every 3 weeks until disease progression or unacceptable toxicity was detected. Forty-three patients were registered and 41 were assessable for response. Seven partial responses were observed (17.1% of the "evaluable" patients; 95% confidence interval [CI], 0-29) with a median response duration of 3.9 months. Stable disease was documented in 2 cases (4.9%). The median survival was 5.8 months (95% CI, 3.4-8.3), resulting in a 1-year survival rate of 23%. Tolerance was acceptable, with the main toxicity being neutropenia. The authors conclude that second-line chemotherapy with docetaxel plus cisplatin for advanced gastric cancer is feasible with an acceptable toxicity level.
    American journal of clinical oncology 11/2004; 27(5):477-80. · 2.21 Impact Factor
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Primary pulmonary non-Hodgkin's lymphoma is a very rare neoplasm. It is represented most commonly by marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue (MALT) type. Although there have been a few reviews of this lymphoma, clinical features, diagnostic procedure, optimal management and prognostic factors have not been well defined. We reviewed the medical records of 24 patients who were pathologically and clinically diagnosed as primary pulmonary lymphoma between September 1995 and June 2003. There were 13 patients with MALT lymphoma and two with MALT lymphoma accompanied by large B-cell lymphoma, seven with diffuse large B-cell lymphoma and two with anaplastic large cell lymphoma. Half the patients were asymptomatic at presentation; 46% had respiratory symptoms and 16.7% had B-symptoms. Initial radiological findings were variable including nodules, masses, infiltrates or consolidation. The majority of patients (66.7%) needed surgical approaches (open thoracotomy or video-assisted thoracoscopy) for definite diagnosis. Bronchoscopy was performed in 83%, but only 30% showed a diagnostic yield. The 13 patients with MALT lymphoma were treated with a variety of modalities such as observation, surgery and single or combination chemotherapy, and combination chemotherapy was administered to 11 patients with non-MALT lymphoma regardless of surgery. The overall survival rate at 3 years for all 24 patients was 86% with a median follow-up of 32 months. Although this entity of lymphoma appears to have a good prognosis, further clinical experience and long-term follow-up are needed to identify prognostic factors.
    Japanese Journal of Clinical Oncology 10/2004; 34(9):510-4. · 1.90 Impact Factor
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: The association between a multiple myeloma and a secondary solid tumor is not well established. Some reports showed an increased risk of secondary solid neoplasms in multiple myeloma patients, but others have not. Three cases of the synchronous occurrence of multiple myelomas and solid tumors, namely, a small cell carcinoma of the lung, an adenocarcinoma of the colon and a squamous carcinoma of the pyriform sinus were experienced at our hospital. Therefore, herein is reported the clinical courses and treatment results. The stage of multiple myeloma was Durie-Salmon stage I in all of three cases; therefore, the solid tumors were treated as a primary target because the prognosis of early stage multiple myeloma is generally better than that of advanced solid tumor, while a smoldering or stage I myeloma do not need primary therapy until progression of the multiple myeloma. Two patients died of their solid tumors, but one patient is alive.
    Cancer Research and Treatment 10/2004; 36(5):338-40. · 1.96 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: A worldwide compassionate-use program has enabled >42,000 patients with advanced non-small cell lung cancer (NSCLC) to receive gefitinib treatment. Here we report the outcome of gefitinib therapy in patients who enrolled in the "Iressa" Expanded Access Program at the Samsung Medical Center. Patients with advanced or metastatic NSCLC who had progressed after prior systemic chemotherapy and for whom no other treatment option was available were eligible to receive gefitinib treatment as part of the Expanded Access Program. A post hoc assessment of potential prognostic factors for response and survival was performed by multivariate analysis. All 111 evaluable patients had stage IV disease; most patients had a baseline performance status of 2 [n = 52 (47%)] or 3 [n = 18 (16%)] and had received >/=2 prior chemotherapy regimens (56%). The objective response rate was 26%, the disease control rate (measured over >/=8 weeks) was 40%, and the 1-year survival rate was 44%. Adenocarcinoma histology was associated with better response and disease control rates, and a performance status of 0-2 was also associated with a better disease control rate. Both of these factors, as well as female gender, were significantly associated with longer survival. Gefitinib was well tolerated; the most common adverse event was grade 1 skin rash. Gefitinib demonstrated significant antitumor activity and a favorable tolerability profile in this series of NSCLC patients with poor prognosis.
    Clinical Cancer Research 08/2004; 10(13):4383-8. · 7.84 Impact Factor
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Herein, a case of solitary, unilateral renal metastasis in a patient with curatively resected thoracic esophageal carcinoma, who achieved a pathological complete remission after neoadjuvant concurrent chemoradiotherapy, is reported. The kidney is the 4(th) or 5(th) most common visceral metastasis site of a primary esophageal carcinoma. More than 50% of renal metastases typically show bilateral involvement. Solitary, unilateral renal metastasis is extremely rare. Renal metastases from a primary esophageal carcinoma are usually latent and its diagnosis is very unusual in a live patient. The solitary renal metastasis in this case was not accompanied by metastases to other sites. The value of a nephrectomy in solitary renal metastasis of esophageal cancer is not known due to the rarity of such cases. A nephrectomy could be justified in limited situations, such as with uncertainty of histological diagnosis, severe life-threatening hematuria, which cannot be controlled by embolization, or solitary renal metastasis with a long disease-free interval.
    Cancer Research and Treatment 08/2004; 36(4):271-4. · 1.96 Impact Factor
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Extrapulmonary small-cell carcinoma (EPSCC) has been recognized as a clinicopathological entity distinct from small-cell carcinoma (SCC) of the lung. This study aimed to review the clinical features, therapy and natural course of patients with EPSCC in Oriental single-institution series. We retrospectively reviewed the medical records of patients with SCC between September 1995 and December 2002. Study eligibility required that patients had pathologically proven SCC in sites other than lung and normal radiological findings of the chest and normal sputum cytology or negative bronchoscopic findings. Twenty-four patients with EPSCC were identified and primary sites were various: uterine cervix in seven (29%), urinary bladder in five, colon or rectum in three, kidney in two and stomach, esophagus, pancreas, common bile duct, larynx, parotid gland, thymus in one each. Sixteen patients (66.7%) had limited disease (LD) and eight had extensive disease (ED). Patients with ED received mostly platinum-based chemotherapy, for which the response rate was 57%, but showed an aggressive natural history, with median overall survival (OS) of 9.2 months. Patients with LD were treated with a variety of therapeutic modalities. LD SCC of the cervix showed a favorable clinical course, with five patients being disease-free with a median follow-up of 28.4 months. Patients with LD SCC of sites other than cervix had an aggressive course with a median OS of 9.6 months. EPSCC was identified in various sites, with the most common primary site being the uterine cervix. Regardless of the primary site or disease stage, EPSCC of sites other than cervix was usually a fatal disease with a discouraging outcome for various treatment modalities.
    Japanese Journal of Clinical Oncology 06/2004; 34(5):250-4. · 1.90 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: Hematopoietic stem cell transplantation (HSCT) results in impaired cell-mediated immunity, which subsequently increases the risk of infection from bacterial, fungal, and viral pathogens. Mycobacterial infections are commonly seen in immunodeficient patients, especially in endemic areas. Several series that have reviewed mycobacterial infections in HSCT patients reported incidences varying from less than 0.1% to 5.5%. From February 1996 to July 2003, we retrospectively reviewed records of 295 adult patients who underwent HSCT at Samsung Medical Center, Korea. Mycobacterial infections were diagnosed in 9 (3.1%) of the 295 transplant recipients. The time from HSCT to tuberculosis (TB) infection ranged from 45 days to 165 days posttransplantation. Analysis at the univariate level indicated that a conditioning regimen with total body irradiation (TBI), chronic graft-versus-host disease, and a previous history of TB infection were significant risk factors for the development of TB infection after HSCT. Multivariate analysis revealed that only a previous history of TB infection and TBI increased the risk of TB infection in HSCT patients (relative risk, 4.8 and 12.5, respectively). Isoniazid prophylaxis in HSCT recipients with only radiologic findings suggestive of past inactive TB infection did not significantly alter the incidence of TB infections (P = .236). In conclusion, a previous history of active TB infection and TBI were significant risk factors of TB infection following HSCT, and isoniazid prophylaxis may benefit HSCT recipients with a previous history of active TB infection.
    International Journal of Hematology 03/2004; 79(2):185-8. · 1.68 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: Primary gastrointestinal (GI) lymphoma accounts for 4% to 20% of all non-Hodgkin's lymphomas (NHL), being the most common extranodal site of presentation. However, the optimal management of intestinal lymphoma has not yet been established. During the period of 1994 to 2001, we retrospectively analyzed the clinical features of 67 intestinal lymphoma patients diagnosed according to the Lewin's definitions. The most frequently involved location was ileocecal (35.8%) followed by small bowel (31.3%), large bowel (19.4%), and multiple GI involvement (13.4%). The estimated 5-year overall survival rate was 53%. Out of all treated patients, 49.2% achieved complete response. The advanced stage, poor performance and T-cell phenotype had an adverse prognostic influence on overall survival. In localized diseases (stage 1 and 2), the primary surgical treatment had the most favorable influence on failure-free survival (P < 0.05). The resection of localized intestinal lymphoma may be appropriate as the primary treatment.
    Leukemia and Lymphoma 02/2004; 45(2):339-44. · 2.61 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: The single agent gemcitabine is the standard first-line treatment for advanced pancreatic cancer. Recent studies of a combination of gemcitabine and 5-fluorouracil (5-FU) revealed that survival data were superior to those with gemcitabine or 5-FU alone. The administration of oral uracil-tegafur (UFT) is more convenient and simulates the effect of a continuous or protracted infusion of 5-FU. Therefore, we conducted a phase II study of gemcitabine combined with UFT in metastatic pancreatic cancer patients and assessed the efficacy and the toxicity of the regimen. Twenty-two pancreatic adenocarcinoma patients (18 males, 4 females) were enrolled from December 2000 to September 2002. The regimen consisted of gemcitabine 1,000 mg/m(2) once weekly for 3 consecutive weeks, and oral UFT 390 mg/m(2)/day (in 3 divided doses) on days 1-14. The cycle was repeated every 28 days. The objective tumor response was evaluated after 2 courses of chemotherapy. 82 cycles were administered in total, with a median of 3 cycles per patient (range 1-6 cycles). The median age was 52 years (range 28-69 years). Response to treatment could be assessed in all patients. The objective response rate was 22.7% (95% CI, 7.8-45.4) with no complete response and 5 partial responses. Four patients (18.2%) had stable disease and 13 patients (59.1%) had a progression. The median time to progression was 4.2 months (range 0.9-13.6). The median overall survival was 5.8 months (range 0.5-13.6). Of 10 patients eligible for the assessment of clinical benefit response, 4 (40%, 95% CI 12.2-73.8) showed clinical benefit. Among 21 patients with baseline CA 19-9 levels, CA 19-9 was reduced by 50% or more in 12 patients (57.1%). The chemotherapy was generally well tolerated and the most common grade 3-4 toxic side effects were neutropenia (18.2%), anemia (4.5%), and diarrhea (4.5%). The combination chemotherapy with gemcitabine and UFT in metastatic pancreatic cancer was tolerable for most patients but showed modest response rates and clinical benefit. However, a randomized phase III study should be conducted in order to further test the efficacy of the regimen.
    Oncology 02/2004; 66(1):32-7. · 2.17 Impact Factor
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Combined chemoradiotherapy (CRT) is the standard treatment modality for limited-stage small-cell lung cancer (LSCLC), but the optimal timing of radiation is controversial. Prolonged oral etoposide has the advantage of prolonged exposure, which possibly leads to improved clinical outcome. We conducted a phase II trial of early concurrent CRT, starting from the very beginning of the first cycle of chemotherapy for previously untreated LSCLC. Chemotherapy was given for six cycles, each consisting of oral etoposide (50 mg/m(2) daily from day 1 to 14) and intravenous cisplatin (75 mg/m(2) on day 1), every 3 weeks. Thoracic radiation therapy was given from day 1 of the first cycle of chemotherapy, administered at 2.0 Gy in 22 daily fractions to a total dose of 44 Gy. Forty-four patients were enrolled. The median age was 60 years (range, 42-77 years), including 15 patients (34%) over 65 years-of-age. We observed a complete response rate of 52% (95% CI, 37-67%), and an overall response rate of 88% in an intent-to-treat (ITT) analysis. Median overall survival was 14.9 months (95% CI, 11.4-18.3 months) and the median time to progression was 10.8 months (95% CI, 9.3-12.4 months) for the ITT population. In 220 cycles, grade 3-4 neutropenia was observed in 48% of cycles and grade 3-4 thrombocytopenia in 30% of cycles. Neutropenic fever was observed in 18 patients (41%). Early concurrent CRT, starting from the very beginning of the first cycle of chemotherapy with prolonged oral etoposide and cisplatin failed to show any improvement in survival compared with other CRT regimens.
    Japanese Journal of Clinical Oncology 01/2004; 33(12):620-5. · 1.90 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: We report a phase II study to evaluate the survival rate, response rate and toxicity of concurrent chemoradiation therapy (CCRT) followed by consolidation chemotherapy (CT) with oral etoposide and cisplatin for patients with locally advanced inoperable non-small cell lung cancer (NSCLC). Fifty-four patients with locally advanced inoperable NSCLC who had received no prior therapy were enrolled into this trial between May 1995 and December 2000. Treatment consisted of two cycles of concurrent CT and four cycles of consolidation CT with oral etoposide (50 mg/m2) on days 1-14 during the CCRT courses and on days 1-21 during the consolidation CT courses, plus cisplatin (75 mg/m2 i.v.) on day 1 of a 28-day cycle. Conventional radiotherapy (1.8 Gy/fraction, 63 Gy over 7 weeks) was delivered from day 1 of the CT. Fifty-two patients were evaluable for response. Twelve patients (22%) achieved complete responses, and 32 patients (60%) achieved partial responses, for an overall response rate of 82% with a median duration of response of 9.1 months. Forty-three per cent developed grade 4 haematological toxicity, 11% grade 3 or 4 oesophagitis and 7% grade 3 or 4 lung toxicity. There were two treatment-related deaths, one from radiation pneumonitis and the other from sepsis. After a median follow-up duration of 50 months (range 20-85), the median overall survival time was 15.3 months (95% CI, 9.7-20.8), and the 1-, 2-, 3-, and 5 year overall survival rates were 62, 40, 30 and 16%, respectively. The duration of median progression-free survival was 12.3 months (95% CI, 7.4-17.3), and the 1-, 2-, 3-, and 5-year progression-free survival rates were 47, 40, 29 and 23%, respectively. Thus, concurrent conventional chest radiotherapy with oral etoposide plus cisplatin followed by consolidation CT led to an encouraging survival rate and prolongation of the time to progression, with moderate toxicity in patients with locally advanced inoperable NSCLC.
    Lung Cancer 11/2003; 42(2):227-35. · 3.39 Impact Factor

Publication Stats

512 Citations
75.16 Total Impact Points

Institutions

  • 2007–2010
    • Konkuk University Medical Center
      • Department of Hematology and Oncology
      Changnyeong, South Gyeongsang, South Korea
  • 2003–2008
    • Sungkyunkwan University
      • School of Medicine
      Seoul, Seoul, South Korea
  • 2005
    • University of South Carolina School of Medicine - Greenville
      Greenville, South Carolina, United States