BACKGROUND: We evaluated the efficacy and toxicity of docetaxel plus cisplatin combination as first-line chemotherapy for advanced gastric cancer. METHODS: Patients with metastatic or recurrent gastric adenocarcinoma, performance score neutropenia was occurred in 7 patients (19.4%) and febrile neutropenia was observed in 6 patients (16.7%). CONCLUSION: Docetaxel plus cisplatin combination as first-line chemotherapy in patients with advanced gastric cancer was effective and tolerable.
Adenocarcinoma ; Cisplatin* ; Drug Therapy ; Drug Therapy, Combination* ; Febrile Neutropenia ; Humans ; Neutropenia ; Stomach Neoplasms*

PURPOSE: We investigated the efficacy and safety of a combination of oxaliplatin, 5-fluorouracil (5-FU), and folinic acid (FA) as first-line palliative chemotherapy for elderly patients with metastatic or recurrent gastric cancer. MATERIALS AND METHODS: The study patients were chemotherapy-naive patients (> 65 years old) with histologically confirmed, metastatic or recurrent gastric cancer. Chemotherapy consisted of oxaliplatin 100 mg/m2 and FA 100 mg/m2 (2-hour infusion), and then 5-FU 2400 mg/m2 (46-hour continuous infusion) every 2 weeks. RESULTS: A total of 37 patients were studied between April 2004 and October 2006. Of the 34 evaluable patients, none achieved a complete response (CR) and 14 achieved a partial response (PR), resulting in an overall response rate of 41.2%. The median time to progression (TTP) was 5.7 months (95% CI: 4.2~6.3 months) and the median overall survival (OS) was 9.8 months (95% CI: 4.4~12.0 months). The main hematologic toxicities were anemia and neutropenia, which were observed in 56.7% and 32.4% of the patients, respectively. Grade 3/4 neutropenia was observed in 8.1% of the patients. None of the patients experienced febrile neutropenia. Peripheral neuropathy occurred in 35.1% of the patients and all were grade 1/2. CONCLUSION: This oxaliplatin/5-FU/FA regimen showed good efficacy and an acceptable toxicity profile in elderly patients with metastatic or recurrent gastric cancer.
Aged* ; Anemia ; Drug Therapy* ; Febrile Neutropenia ; Fluorouracil* ; Humans ; Leucovorin* ; Neutropenia ; Peripheral Nervous System Diseases ; Stomach Neoplasms*

PURPOSE: Paclitaxel (P) and gemcitabine (G) are clinically synergistic in small cell lung cancer (SCLC). We evaluated the efficacy of PG as a salvage treatment for SCLC patients whose disease progressed after a platinum-containing regimen. MATERIALS AND METHODS: Eligibility included histologically confirmed SCLC, one dimensionally measurable disease, Eastern Cooperative Oncology Group performance status 0-2, and progressive disease after platinum-based chemotherapy. Treatment consisted of P (80 mg/m2) and G (1,000 mg/m2) on days 1 and 8 of each cycle of 21 days until disease progression. RESULTS: Thirty-three patients seen between December 2005 and February 2009 were selected into this study. Thirty patients (91%) had received irinotecan-platinum, and three had received etoposide-platinum. Sixteen patients (49%) had a treatment-free interval of less than 3 months. The overall response rate was 30.3% (29.4% in sensitive relapse and 31.3% in refractory relapse). The median time to progression was 12.0 weeks and median overall survival (OS) 31.0 weeks, with a 1-year OS rate of 30.3%. Toxicities were moderate and manageable with 18.2% grade (G) 4 neutropenia, 24.2% G3 thrombocytopenia, 6.1% G3 sensory neuropathy, and 3% G3 asthenia. One patient developed febrile neutropenia. CONCLUSION: Second-line paclitaxel and gemcitabine were well-tolerated and moderately active in SCLC patients previously treated with platinum-based chemotherapy.
Asthenia ; Disease Progression ; Drug Therapy ; Febrile Neutropenia ; Humans ; Neutropenia ; Paclitaxel* ; Recurrence ; Small Cell Lung Carcinoma* ; Thrombocytopenia

PURPOSE: Fluoropyrimidine (F) and platinum (P) combination chemotherapy has been widely used for the first line treatment of advanced gastric cancer (AGC). Docetaxel (D) has shown promising activity in this disease. The present study retrospectively investigated the efficacy of D monotherapy as salvage chemotherapy for AGC that is failing F and P combination chemotherapy. MATERIALS AND METHODS: A total of 34 patients, fitting the eligibility criteria, were included in this study. D was administered at a dose of 75 mg/m2 IV every 3 weeks, with dexamethasone prophylaxis. Twenty-nine patients had measurable lesions. The median treatment-free interval was 38.5 days, and 91.2% of patients had progressed within 4 months of withdrawal of the first line chemotherapy. RESULTS: A total of 133 cycles of D were administered, with a median of 3.5 (1~8) cycles. From an intention-to-treat analysis, 6 patients achieved partial responses (PR), with a response rate of 20.7% (95% CI, 6.0~35.4). The duration of objective PRs in these six were 2.3+, 2.5+, 2.9, 3.0+, 6.2 and 6.8 months, respectively. Six patients showed a stable disease, but 15 showed progression. The median time to progression was 4.2 months (95% CI, 2.8~5.5), with a median overall survival since the start of D monotherapy of 8.4 months (95% CI, 5.5~11.3). Grade 3/4 neutropenia and febrile neutropenia occurred in 12.9% of patients and 3.1% of cycles. The incidence of grade 3 or worse non-hematological toxicities were as follows; peripheral sensory neuropathy 9.7%, asthenia 3.2% and allergic reaction 2.7%. CONCLUSION: Docetaxel, 75 mg/m2, is active in AGC as second-line chemotherapy after failure of prior exposure to the F and P combination chemotherapy, with a favorable toxicity profile.
Asthenia ; Dexamethasone ; Drug Therapy* ; Drug Therapy, Combination* ; Febrile Neutropenia ; Humans ; Hypersensitivity ; Incidence ; Neutropenia ; Platinum* ; Retrospective Studies ; Salvage Therapy ; Stomach Neoplasms*

PURPOSE: We conducted a phase II study of docetaxel and ifosfamide chemotherapy for patients with platinum- resistant or refractory non-small-cell lung cancer (NSCLC) to evaluate the response and toxicity profiles as a salvage treatment. MATERIALS AND METHODS: Between July 2000 and July 2004, 40 patients who had previously received platinum- based regimen as the first-line or second-line therapy were enrolled in this study. The treatment consisted of a docetaxel 75 mg/m2 intravenous infusion on day 1 and intravenous ifosfamide 3 g/m2 with Mesna(R) uroprotectione on day 1 through 3. This regimen was repeated every 3 weeks. RESULTS: One hundred thirty cycles of treatment were given, with a median of 3 cycles (range: 2~6 cycles). All the patients were evaluable for the response rate and toxicity profile. The major toxicity was myelosuppression. Grade 3~4 neutropenia occurred in 30 patients (75%) during treatment. Febrile neutropenia occurred in 16 patients (40%). Five of 40 patients (12.5%) had a partial response (95% confidence interval, 3.3~21.7%). The median time to disease progression was 2.65 months (range: 2.02~3.20 months), and the median survival was 5.24 months (range: 2.99~7.49 months). CONCLUSION: Salvage chemotherapy with docetaxel and ifosfamide showed a low efficacy and a high proportion of severe neutropenia in patients with platinum-resistant or refractory advanced NSCLC.
Carcinoma, Non-Small-Cell Lung* ; Disease Progression ; Drug Therapy ; Febrile Neutropenia ; Humans ; Ifosfamide* ; Infusions, Intravenous ; Lung Neoplasms ; Neutropenia ; Salvage Therapy

PURPOSE: We evaluated the easily-assessable risk factors to predict bacteremia in children with febrile neutropenia, who received anticancer chemotherapy. METHODS: We retrospectively reviewed 46 children who had febrile neutropenia caused by anticancer chemotherapy between March, 1993 and February, 1997. The patients with localized infection on presentation were not eligible for this study. We evaluated the correlation between bacteremia and some variables, including absolute neutrophil count (ANC), absolute monocyte count (AMoC) and absolute phagocyte count (APC). RESULTS: There was total of 147 consecutive episodes of fever in 46 children, with 90 episodes of fever were noted in neutropenic patients without localized infection. There were 20 episodes of bacteremia (22.2%) in 90 episodes of febrile neutropenia. The mean ANC of 365.5 +/- 448.3/microliter, mean AMoC 132.3 +/- 310.4/microliter and mean APC 502.0 +/- 603.3/microliter did not show significant correlation with bacteremia. There was no statistically significant correlation between bacteremia and ANC or AMoC. There was higher risk of bacteremia in patients with AMoC less than 100/microliter as compared with patients with AMoC above than 100/microliter (odds ratio : 1.39, 95%CI : 0.41-4.69). There were 17 episodes of bacteremia (28.8% of 59 febrile episodes) in patients with APC less than 500/microliter and 3 episodes of bacteremia (9.7% of 31 febrile episodes) in patients with APC above than 500/microliter (P=0.03, odds ratio : 3.78, 95%CI : 1.01-14.10). CONCLUSION: There was a statistically-significant correlation between bacteremia and APC with higher risk of bacteremia in patients with APC less than 500/microliter. Trials should be conducted to test whether APC may be used to assign some children to less intensive or outpatient antibiotic therapy at the time of presentation of febrile neutropenia.
Bacteremia* ; Child* ; Drug Therapy* ; Febrile Neutropenia* ; Fever ; Humans ; Monocytes ; Neutropenia ; Neutrophils ; Odds Ratio ; Outpatients ; Phagocytes ; Retrospective Studies ; Risk Factors*

PURPOSE: The objective of this multicenter phase II study was to evaluate the efficacy and safety of irinotecan and cisplatin combination chemotherapy in metastatic, unresectable esophageal cancer. MATERIALS AND METHODS: Patients were treated with irinotecan 65 mg/m² and cisplatin 30 mg/m² on days 1 and 8 of each 21-day treatment cycle. The primary endpoint was response rate, and secondary endpoints were survival, duration of response, initial metabolic response rate, and toxicity. RESULTS: A total of 27 patients with squamous cell histology were enrolled in the study. The median age of the patients was 61 years. The objective response rate of the 20 patients in the perprotocol group was 30.0% (90% confidence interval [CI], 13.2 to 46.9). The median follow-up duration was 10.0 months, and the median progression-free survival and overall survival were 4.5 months (95% CI, 1.6 to 6.2) and 8.8 months (95% CI, 4.7 to 10.5), respectively. Four of 13 patients (30.8%) evaluated showed initial metabolic response. The median duration of response for partial responders was 5.0 months (range, 3.4 to 8.0 months). The following grade 3/4 treatment-related hematologic toxicities were reported: neutropenia (40.7%), anaemia (22.2%), and thrombocytopenia (7.4%). Two patients experienced febrile neutropenia. The most common grade 3/4 non-hematologic toxicities were asthenia (14.8%) and diarrhoea (11.1%). CONCLUSION: Irinotecan and cisplatin combination chemotherapy showed modest anti-tumour activity and manageable toxicity for patients with metastatic, unresectable esophageal cancer.
Asthenia ; Cisplatin* ; Disease-Free Survival ; Drug Therapy, Combination* ; Epithelial Cells ; Esophageal Neoplasms* ; Febrile Neutropenia ; Follow-Up Studies ; Humans ; Neutropenia ; Thrombocytopenia

PURPOSE: With the increased use of chemotherapy for non small cell lung cancer (NSCLC), a growing group of patients can now be considered for second-line chemotherapy. However, guidelines for the second line treatment remain to be developed. The objective of this study was to evaluate the efficacy and safety of the gemcitabine and vinorelbine combination therapy in patients with advanced NSCLC, pretreated with taxane and platinum based regimens. Gemcitabine has already demonstrated activity in this patient group, with the combination therapy having been reported to be well tolerated in previous phase I/II studies. MATERIALS AND METHODS: Forty two patients with advanced NSCLC (stages III/IV), having received prior taxane and platinum based chemotherapy, with an ECOG performance status (PS) 0~2, and unimpaired hematopoietic and organ function, were treated with vinorelbine, 20 mg/m2, followed by gemcitabine, 1, 000 mg/m2, both administered on days 1, 8 and 15, every 4 weeks. RESULTS: Out of the 42 patients enrolled, 41 were evaluable for their response, and all 42 for their toxicity. The patient's characteristics were as follows; median age=60 years (42~73), median PS=1 (range 0~2), a gender ratio 31: 11 males/females, with stages IIIA, IIIB and IV in 3, 14 and 25 cases. The objective responses included a partial response (PR) 8/41 (19.5%), a stable disease 15/41 (36.6%) and a progressive disease 18/41 (43.9%). The median time-to progression (TTP) and survival were 4 months, ranging from 2 to 14 months, and 8 months, ranging from 2 to 17+ months, respectively. Grade 3 neutropenia was seen in 19% of the patient, and there was no grade 4 neutropenia or episodes of febrile neutropenia. No grade 4 thrombocytopenia or other grade 3/4 non-hematological toxicities were observed. CONCLUSION: The combination of gemcitabine/vinorelbine is active and well tolerated in patients with advanced NSCLC having failed prior taxane/platinum therapy.
Carcinoma, Non-Small-Cell Lung* ; Drug Therapy* ; Febrile Neutropenia ; Humans ; Neutropenia ; Platinum ; Small Cell Lung Carcinoma ; Thrombocytopenia

PURPOSE: Primary prophylaxis with granulocyte colony-stimulating factor can effectively prevent febrile neutropenia (FN) during breast cancer treatment. The aims of this study were to evaluate the incidence of FN and the ANC profile in patients undergoing chemotherapy and pegfilgrastim primary prophylaxis. METHODS: Patients receiving 6 cycles of adjuvant docetaxel, doxorubicin, and cyclophosphamide (TAC) chemotherapy were included in this study. Pegfilgrastim was administered with analgesics 24 hours after treatment. Laboratory tests were performed on day 0 (before chemotherapy) and ANC was measured daily starting day 5 until it were restored to 1,000/mm3. Bone pain was checked via the numeral rating scale (NRS). RESULTS: A total of 61 patients and 366 cycles were evaluated. Mean age was 49.2 ± 7.1 years. FN was seen in 5 patients (16.4%) and 12 cycles (3.3%) with pegfilgrastim. Grades 3 and 4 neutropenia was seen in 91.5% of cycles with FN. The ANC nadir was most commonly seen at day 7 and the mean ANC nadir depth was 265.7/m3. Age was negatively correlated with nadir depth (r = −0.137, P = 0.009). Severe pain higher than NRS 7 occurred in less than 20% of patients after the administration of pegfilgrastim. CONCLUSION: Incidence of FN was low during the chemotherapy by primary prophylaxis with pegfilgrastim. The ANC nadir was seen on day 7 after chemotherapy. Bone pain with pegfilgrastim was well tolerated during TAC chemotherapy.
Analgesics ; Breast Neoplasms* ; Breast* ; Chemotherapy, Adjuvant ; Cyclophosphamide ; Doxorubicin ; Drug Therapy* ; Febrile Neutropenia* ; Granulocyte Colony-Stimulating Factor ; Humans ; Incidence ; Neutropenia

PURPOSE: Doxorubicin/cyclophosphamide followed by docetaxel chemotherapy (AC-D) is an intermediate risk factor (incidence of 10%–20%) for febrile neutropenia (FN) in breast cancer. However, the reported incidence of FN while using this regimen was obtained mostly from Western breast cancer patients, with little data available from Asian patients. This study aimed to assess the incidence of FN in Korean breast cancer patients and to describe clinical variables related to FN. METHODS: From September 2010 to February 2013, data from the Yonsei Cancer Center registry of breast cancer patients who received neoadjuvant or adjuvant chemotherapy with four cycles of AC-D (60 mg/m2 doxorubicin, 600 mg/m2 cyclophosphamide every 3 weeks for four cycles followed by 75 mg/m2 or 100 mg/m2 docetaxel every 3 weeks for four cycles) were analyzed. The incidence of FN, FN associated complications, dose reduction/delays, and relative dose intensity (RDI) were investigated. RESULTS: Among the 254 patients reported to the registry, the FN incidence after AC-D chemotherapy was 29.5% (75/254), consisting of 25.2% (64/254) events during AC and 4.7% (12/254) during docetaxel chemotherapy. Dose reductions, delays, and RDI less than 85.0% during AC were observed in 16.5% (42/254), 19.5% (47/254), and 11.0% (28/254) of patients, respectively. Patients with FN events frequently experienced dose reduction/delays, which eventually led to a decreased RDI. CONCLUSION: The incidence of FN during AC-D neoadjuvant or adjuvant chemotherapy was higher than expected in Korean breast cancer patients. Whether these patients should be classified as a high-risk group for FN warrants future prospective studies.
Asian Continental Ancestry Group ; Breast Neoplasms* ; Breast* ; Chemotherapy, Adjuvant ; Chemotherapy-Induced Febrile Neutropenia ; Cyclophosphamide ; Doxorubicin ; Drug Therapy* ; Febrile Neutropenia* ; Female* ; Humans ; Incidence* ; Prospective Studies ; Risk Factors