Biomedical subjects

G Samonis

Publications and source records attributed to G Samonis.

At least 55 records · Page 3Linked to original sources

PubMed2001

Oxaliplatin in combination with infusional 5-fluorouracil and leucovorin every 2 weeks as first-line treatment in patients with advanced colorectal cancer: a phase II study.

PURPOSE: To evaluate the efficacy and safety of oxaliplatin (L-OHP) in combination with leucovorin (LV)-modulated bolus plus infusional 5-fluorouracil (5-FU; de Gramont schedule) every 2 weeks in chemotherapy-naive patients with advanced colorectal cancer (CRC). PATIENTS AND METHODS: Thirty-two patients (median age: 69 years) with histologically confirmed and two-dimensionally measurable metastatic CRC were enrolled. The patients' performance status (WHO) was 0 in 14 (44%), 1 in 15 (47%), and 2 in 3 (9%) patients. Twenty (62.5%) patients had at least two metastatic sites. LV was administered at a dose of 200 mg/m2/day as a 2-hour intravenous infusion, followed by 5-FU as an intravenous bolus at the dose of 400 mg/m2 and then, as a 22-hour continuous infusion at the dose of 600 mg/m2/day for 2 consecutive days. L-OHP was administered on day 1 at the dose of 85 mg/m2 as a 2-hour infusion in parallel with LV but using different infusion lines. Treatment was administered every 2 weeks. RESULTS: In an intention-to-treat analysis, 2 (6.2%) complete and 9 (28%) partial responses (28%; odds ratio 34.2%; 95% confidence interval 17.92-50.83%) were achieved while 8 (25%) patients had stable disease and 13 (41%) progressive disease. The median duration of response was 5 months, but the median time to progression has not yet been reached. After a median follow-up period of 11 months, the median survival has not yet been attained, but the projected probability for 1-year survival was 72%. Grade 3/4 neutropenia occurred in 16 (50%) patients while 1 (3%) of them developed febrile neutropenia. There was no treatment-related death. Peripheral neuropathy grade 2 and > or =3 occurred in 5 (16%) and 7 (21%) patients, respectively. CONCLUSIONS: The bimonthly administration of L-OHP in association with LV-modulated bolus plus infusional 5-FU ('de Gramont' regimen) is a well-tolerated and effective front-line treatment for metastatic CRC.

Actuarial Analysis↗

PubMed2001

Effect of ketoconazole, itraconazole and fluconazole on the gastrointestinal colonization of mice by Candida albicans.

Crl:CD1 (ICR) BR mice were colonized in the gastrointestinal (GI) tract with Candida albicans. This strain was susceptible to ketoconazole (MIC=0.25 microg/ml), itraconazole (minimum inhibitory concentration, MIC=0.25 microg/ml), and fluconazole (MIC=4 microg/ml). Subsequently the animals received monotherapy with ketoconazole by mouth (equivalent to human dose of 2.9 mg/kg/day), or itraconazole by mouth (equivalent to human dose of 2.9 mg/kg/day), or fluconazole either subcutaneously (equivalent to human dose of 2.2 mg/kg/day), or by mouth (equivalent to human dose of 2.2 mg/kg/day), for 10 days. Quantitative stool cultures at the end and one week after the end of treatment revealed that all three azoles caused a small and statistically non significant reduction of C. albicans concentration in the stools. The different route of administration of fluconazole did not produce different results. In conclusion, these azoles, used at the present doses and schedules, have minimal effect on murine GI colonization by this strain of C. albicans which is susceptible but with rather increased MICs.

Animals↗

PubMed2000

Recent experience with Pseudomonas aeruginosa bacteremia in patients with cancer: Retrospective analysis of 245 episodes.

BACKGROUND: Pseudomonas aeruginosa bacteremia is a serious and possibly fatal condition in patients with cancer. OBJECTIVES: To ascertain the frequency, demographics, and predisposing factors for P. aeruginosa bacteremia in patients with cancer and to determine the efficacy of various therapeutic regimens. SUBJECTS AND METHODS: Patient records of the Clinical Microbiology Laboratory, The University of Texas, M. D. Anderson Cancer Center, Houston, were reviewed. From January 1, 1991, through December 31, 1995, 245 eligible cases of P. aeruginosa bacteremia were identified. We examined the patient records for the underlying malignant neoplasm and its management, symptoms and signs of infection, culture results of appropriate specimens, antibiotic therapy, and outcome. We also compared our present experience with a previous analysis from this institution covering the period from January 1, 1972, to December 31, 1981. RESULTS: The incidence of P. aeruginosa bacteremia has decreased compared with the previous study (2.8 vs 4.7 cases per 1000 admissions). It was most common in patients with acute leukemia (55 of 1000 registrations), and the frequency in this disease has not changed. Half of the patients were not in the hospital when they developed their infection. The overall cure rate was 80%, which was a significant (P<.001) increase compared with the 62% cure rate in the previous study. In this study, no significant difference in the cure rates was observed between monotherapy with a beta-lactam and combination therapy overall (P = .72), and in patients with shock (P = 1.0) and those with pneumonia (P = .60). The patients' initial neutrophil counts were not of prognostic value; however, the cure rate depended on subsequent changes in neutrophil count during therapy. CONCLUSIONS: The frequency rate of P. aeruginosa bacteremia has decreased in patients with solid tumors but has remained unchanged in patients with acute leukemia. Antibiotic regimens for empirical therapy of neutropenic patients and especially patients with acute leukemia should still provide coverage against P. aeruginosa.

Acute Disease↗

PubMed2000

A dose escalation study of weekly docetaxel in patients with advanced solid tumors.

PURPOSE: To determine the maximum tolerated dose (MTD) and the dose-limiting toxicity (DLT) of weekly administration of docetaxel for three consecutive weeks every 4 weeks in patients with advanced solid tumors. PATIENTS AND METHODS: A total of 26 patients with malignant tumors refractory to conventional treatment were enrolled in this phase I study; their median age was 62 years. Of the 26 patients, 16 (62%) had previously received more than one chemotherapy regimen and 17 (65%) had previously received taxanes in a 3-week schedule. Docetaxel was administered after appropriate premedication at escalating doses (starting dose 30 mg/m2) as a 1-h i.v. infusion for three consecutive weeks in cycles of 4 weeks. RESULTS: A total of 68 chemotherapy cycles were administered with a median of three cycles per patient (range one to six). The DLT was reached at 45 mg/m2 per week and the dose-limiting events were grade 4 neutropenia, febrile neutropenia, and treatment delay due to incomplete hematologic recovery. The MTD was defined at a dose of 42 mg/m2/week. Grade 3/4 neutropenia occurred in seven patients (27%) (10% of cycles), and four patients (15%) developed febrile neutropenia. There were no deaths due to sepsis. Grade 2 peripheral neurotoxicity was observed in two patients (8%), grade 2 and 3 fatigue in 14 (54%), grade 2 edema in seven (27%), mild allergic reactions in two (8%) and lacrimation in three (12%). One (4%) complete response and eight (35%) partial responses (overall response rate 39%) were observed in 23 evaluable patients. Stable disease and progressive disease were observed in six patients (26%) and eight patients (35%), respectively. All responses were observed in patients with metastatic breast cancer, one of whom had progressed on paclitaxel-based and two of whom had progressed on docetaxel-based chemotherapy. CONCLUSIONS: The weekly administration of docetaxel for three consecutive weeks every 28 days is a feasible schedule with a favorable toxicity profile, and can be given on an outpatient basis. Moreover, this schedule of docetaxel administration seems to have an enhanced efficacy, especially in patients with advanced breast cancer who have failed front-line taxane-based chemotherapy.

Adult↗

PubMed2000

Successful conservative treatment of neutropenic enterocolitis complicating taxane-based chemotherapy: a report of five cases.

Five cases of acute neutropenic enterocolitis complicating taxane-based chemotherapy are described. During a 34-month period, our department administered 4,600 courses of taxane-based (paclitaxel and docetaxel) chemotherapy to 800 cancer patients. Seven to 10 days postchemotherapy in five patients (0.1% of the given courses), neutropenic fever, abdominal pain, rebound tenderness, and grade II-IV diarrhea (bloody in two cases) developed. Two patients had oral candidiasis, and in two others septic shock developed. Computed tomography scans of the abdomen revealed in all patients thickening of the colon wall and pericolic edema, and a pericolic abscess was revealed in three of them. Both clinical and radiologic findings supported the diagnosis of acute neutropenic enterocolitis. All patients were successfully treated with broad-spectrum antibiotics and recombinant human granulocyte colony-stimulating factor. In conclusion, acute neutropenic enterocolitis is a severe complication of taxane-based chemotherapy. Early diagnosis and appropriate conservative treatment leads to complete recovery. Although rare, this infection is less often associated with other chemotherapeutic regimens.

Acute Disease↗

PubMed2000

Infection and immunity in chronic lymphocytic leukemia.

Patients having chronic lymphocytic leukemia (CLL) are at increased risk for infectious morbidity and mortality. The predisposition to infections in CLL patients has many components, including both immunodeficiency related to the leukemia itself (humoral and cellular immune dysfunction) and the results of cumulative immunosuppression related to CLL treatment. The risk of infectious complications increases with the duration of CLL, reflecting the natural history of the disease and the cumulative immunosuppression related to its treatment. Hence, in early, untreated CLL, the infectious risk is mainly related to hypogammaglobulinemia, and infections by encapsulated bacteria are common. However, in patients having advanced CLL, particularly those who receive the newer purine analogues, neutropenia and defects in cell-mediated immunity appear to be the major predisposing factors. An expanded spectrum of pathogens, including opportunistic fungi, Pneumocystis carinii, Listeria monocytogenes, mycobacteria, and herpesviruses, are seen in that setting. The changing spectrum of infections in this latter group of patients mandates a newer approach to prophylaxis and therapy.

Agammaglobulinemia↗

PubMed2000

Phase I study of the gemcitabine/oxaliplatin combination in patients with advanced solid tumors: a preliminary report.

The purpose of this study was to determine the maximum tolerated dose and evaluate the dose-limiting toxicities of the gemcitabine/oxaliplatin combination in patients with advanced-stage solid tumors. Of the 48 enrolled patients, 35% had first-line, 23% had second-line, and 42% had third-line therapy. Patients received escalating doses of 1,000 to 1,600 mg/m2 gemcitabine on days I and 8 plus 60 to 120 mg/m2 oxaliplatin on day 8, every 21 days. The dose-limiting toxicities (first nine dose levels) were grade 4 neutropenia, grade 3 asthenia, and grade I to 3 neutropenia or thrombocytopenia. One hundred fifty-three cycles have been administered without any febrile neutropenia or toxic death. Grade 3-4 neutropenia and grade 3 thrombocytopenia were noted in 13 (9%) and seven (5%) cycles, respectively. Nonhematologic toxicity has been mild; the most common was grade 2 to 3 asthenia occurring in 29% of cycles. Among 30 evaluable patients, four partial responses have been observed (response rate, 13%). In this phase I study, the maximum tolerated dose of this drug combination has not yet been reached, although gemcitabine up to 1,600 mg/m2 (days I and 8) plus oxaliplatin up to 120 mg/m2 (day 8) was active and well tolerated, warranting further evaluation in phase II studies.

Aged↗

PubMed1999

Salvage chemotherapy in anthracycline-pretreated metastatic breast cancer patients with docetaxel and gemcitabine: a multicenter phase II trial. Greek Breast Cancer Cooperative Group.

PURPOSE: The activity of the docetaxel-gemcitabine combination in women with disease progression after initial chemotherapy for metastatic breast cancer (MBC) was investigated in a multicenter phase II study. PATIENTS AND METHODS: Fifty-two patients with metastatic breast cancer who had disease relapse or progression after completion of an anthracycline-based front-line regimen were treated with gemcitabine 900 mg/m2 on day 1 and day 8 and docetaxel 100 mg/m2 on day 8. G-CSF 150 mucg/m2/d s.c. was given from day 9 to day 16 and the treatment was repeated every three weeks. The patients' median age was 57 years and the performance status (WHO) was 0 for 26, 1 for 20 and 2 for 6 patients. The treatment was second-line for 27 (52%) and > or = third-line for 25 (48%) patients. All patients were evaluable for response and toxicity. RESULTS: Complete response occurred in seven (14%) patients and partial response in 21 (40%) for an overall response rate of 54% (95% confidence interval (95% CI): 40%-67%). Fifteen (29%) patients had stable disease and nine (17%) progressive disease. Of 25 patients previously treated with taxanes. 11 (44%) responded (1 CR, 10 PR). Interestingly, in four patients with disease progression while receiving docetaxel or paclitaxel monotherapy, the docetaxel + gemcitabine combination achieved partial responses. Responses were observed at all metastatic sites (local disease 62%, lymph nodes 58%, skin 44%, lung 47% and liver 36%) with a median duration of response of 3.6 months (range 1-16) and a median time to disease progression of eight months (range 2-18.5). Grade 3 neutropenia developed in 10 (19%) and grade 4 in five (10%) patients. Neutropenia was associated with infection in four patients without toxic deaths. Grade 3 thrombocytopenia developed in nine (17%) patients and grade 4 in two (4%). Non-hematologic toxicity was usually mild. CONCLUSION: The docetaxel-gemcitabine combination is an active and well tolerated salvage treatment in patients with MBC. Previous treatment with taxanes does not preclude a good clinical response to this regimen.

Adult↗

PubMed1999

Front-line treatment of metastatic breast cancer with docetaxel and epirubicin: a multicenter dose-escalation study. The Greek Breast Cancer Cooperative Group (GBCCG).

PURPOSE: To determine the maximum tolerable dose (MTD) and the dose-limiting toxicity (DLT) of docetaxel (D) in combination with epirubicin (Epi) in patients with advanced breast cancer. PATIENTS AND METHODS: Forty-seven chemotherapy-naïve metastatic breast cancer patients aged < 75 years with PS (WHO) 0-2 and adequate bone marrow, renal, liver and cardiac function, were enrolled in the study. Epi was given as a five-min bolus i.v. infusion on day 1 (d1) in escalated doses with increments of 10 mg/m2; D was given in a one-hour infusion after appropriate premedication on either day 1 or on day 2 in escalated doses with increments of 10 mg/m2. The patients' median age was 60 years, 42 (89%) had a PS (WHO) 0-1, 16 (34%) were premenopausal and 25 (53%) had visceral disease. RESULTS: When the two drugs were given on the same day, the MTD1 was reached at the doses of Epi 60 mg/m2 and D 80 mg/m2; administration of G-CSF could not result in a dose intensification. When the drugs were given on two consecutive days, the MTD2 was reached at the doses of Epi 80 mg/m2 (d1) and D 90 mg/m2 (d2). The dose-limiting events were febrile neutropenia and grade 4 neutropenia, which developed in 30 (64%) patients during the study; among 227 delivered cycles grade 3-4 neutropenia occurred in 64 (28%) cycles but only 22 (10%) of them were complicated by fever. There were no septic deaths. Grade 1-2 neurosensory toxicity occurred in nine (19%) patients, mild edema in eight (17%) and allergic reactions in five (11%). Four (9%) patients presented a greater than 10% decrease of LVEF and treatment discontinuation was required in two of them; none of the patients developed congestive heart failure. Nevertheless, one patient suddenly died 10 days after treatment initiation of myocardial ischemia, and this death is considered treatment-related. Five (14.7%) complete and thirteen (38.2%) partial responses (ORR: 53.9%; 95% confidence interval: 36.1%-69.7%) were observed in 34 evaluable patients. Ten (29.4%) and six (17.6%) patients had stable and progressive disease, respectively. The median duration of response and time to tumor progression were five and seven months, respectively. The median survival has not yet been reached. CONCLUSIONS: The combination of epirubicin and docetaxel is a feasible and well tolerated regimen, but the MTD depends on the administration schedule of the drugs.

Adult↗

PubMed1999

First-line treatment with mitoxantrone, methotrexate, vincristine, and carboplatine (MIMOC) plus cyclical hormonotherapy with tamoxifen and megestrol acetate in advanced breast cancer.

Fifty patients with stage IIIB and IV breast cancer entered a prospective study receiving combination chemotherapy consisting of mitoxantrone (8 mg/m2) on day 1, methotrexate (30 mg/m2) on day 1, vincristine (1 mg/m2) on day 2, and carboplatine (250 mg/m2) on day 2 (MIMOC), plus cyclical hormonotherapy with tamoxifen (20 mg daily, days 1-10) and megestrol acetate (160 mg daily, days 11-21). The regimen was repeated every 3 weeks. None had received chemotherapy for advanced disease, although 17 patients had previously received adjuvant chemotherapy and 21 had received adjuvant hormonotherapy with tamoxifen. Twenty-seven patients had positive estrogen receptor (ER+) status, and 23 negative estrogen receptor (ER-) status. Response was observed in 31 (62%) of the 50 analyzed patients (95% CI: 48.5-75.4%), with 5 complete responses (10%). A significantly better response rate was observed in ER+ patients (p = 0.03). The median duration of response was 16 months, and the median time to disease progression was 18 months. The median overall survival was 19 months (27 for responders and 7 for nonresponders). ER+ patients had a higher probability of survival (p = 0.02). Toxicity was moderate. Nausea/vomiting and myelotoxicity were the main side effects. In conclusion, MIMOC plus cyclical hormonotherapy represents a well-tolerated and effective first-line treatment for advanced breast cancer. The observed difference in response and survival in favor of ER+ patients warrants further investigation.

Adult↗

PubMed1999

First-line treatment of metastatic breast cancer with mitoxantrone, vinorelbine, and carboplatin.

A phase II trial was conducted with mitoxantrone (12 mg/m2, day 1), vinorelbine (30 mg/m2, day 1), and carboplatin (250 mg/m2, day 2) every 21 days. Fifty eligible women who had not received prior chemotherapy for metastatic breast cancer (MBC) entered the study. Objective responses were observed in 28 patients (56%; 95% confidence interval: 42.4-69.74%), with 4 complete (8%) and 24 partial responses (48%). Stable disease was observed in 12 patients (24%) and disease progression in 10 (20%). Responses were documented in all involved sites. The median duration of response was 6 months and the median time to tumor progression 8 months. The median survival was 26 months and the estimated 2-year survival was 52%. Grade 3/4 neutropenia was observed in 29 patients (58%) with four neutropenic episodes. Grade 3/4 anemia and thrombocytopenia was observed in 7 (14%) and 11 (22%) patients, respectively. Other toxicities included grade 2/3 nausea and vomiting in 26 patients (52%) and grade 1/2 alopecia in 38 (76%). Grade 1/2 neurosensory toxicity occurred in four patients (8%). In conclusion, this three-drug regimen is effective and well tolerated for the treatment of MBC.

Adult↗

PubMed1999

Carboplatin, methotrexate and 5-fluorouracil in combination with medroxyprogesterone acetate (JMF-M) in the treatment of advanced or recurrent endometrial carcinoma: A Hellenic cooperative oncology group study.

Twenty-three patients with advanced or recurrent endometrial carcinoma entered a prospective study of chemotherapy which consisted of carboplatin (300 mg/m2), methotrexate (30 mg/m2), and 5-fluoruracil (500 mg/m2) given on day 1, in a 3-weekly schedule, in combination with medroxyprogesterone acetate (MPA): 300 mg daily, p. o., until progression (JMF-M regimen). None had received prior chemotherapy and/or hormonotherapy for metastatic disease. Ten patients had received radiotherapy. Response to treatment was evaluated every two courses. Objective response was seen in 17 of the 23 patients (74%, 95% confidence interval = 52-90%), with 2 long-lasting complete responses (9%). The median response duration was 10+ months (3-45+). The median survival was 16+ months (2-45+). The 2 complete responders, the first in the lung and the second in groin nodes, are without evidence or recurrence after 32 and 45 months, respectively. The regimen was given on an outpatient basis and was well tolerated. The major toxic effects were myelosuppression (less than 14% leukopenia, anemia and thrombocytopenia). The MPA-related side effects were: weight gain (22%), hypertension (17%) and thromboplebitis (17%). In 2 patients, consolidation treatment with MPA was discontinued because of thromboplebitis. In conclusion, the JMF-M regimen is highly active with an acceptable toxicity in patients with recurrent or metastatic endometrial carcinoma.

Adult↗

PubMed1999

Ceftriaxone and dexamethasone affecting yeast gut flora in experimental mice.

Crl:CD1 (ICR) BR mice were fed regular food or food containing Candida albicans to induce gastrointestinal (GI) colonization by the yeast. Groups of colonized mice were subsequently treated with either ceftriaxone for 10 days or dexamethasone for 10 or 21 days. Another group of colonized mice was treated with the combination of ceftriaxone, given for 10 days, and dexamethasone given for 21 days. Other colonized mice received normal saline, and non-colonized mice received the same drugs or saline, serving as controls. Candida-colonized mice, treated either with ceftriaxone or with dexamethasone alone, had significantly increased levels of GI colonization by the yeast. Colonized mice treated with the combination of the antibiotic with dexamethasone had stool concentrations of Candida similar to those of mice treated with the antibiotic alone. Saline did not affect Candida stool concentration. Yeasts were not found in the stools of non-colonized mice treated with the study drugs or saline. There was no evidence of Candida dissemination to internal organs in any group.

Animals↗

PubMed1999

Dose-escalation study of docetaxel in combination with mitoxantrone as first-line treatment in patients with metastatic breast cancer.

PURPOSE: To define the maximum-tolerated dose (MTD) and the dose-limiting toxicities (DLTs) of docetaxel in combination with mitoxantrone in patients with metastatic breast cancer (MBC). PATIENTS AND METHODS: Forty-one chemotherapy-naive patients with MBC (median age, 61 years) were enrolled. Thirty-eight (93%) had performance status (World Health Organization [WHO]) 0, 29 (71%) were postmenopausal, and 21 (51%) had estrogen receptor-negative tumors. Patients received escalated doses of docetaxel (75 to 100 mg/m2) on day 1 and mitoxantrone (8 to 22 mg/m2) on day 8. Treatment was repeated every 3 weeks. RESULTS: A total of 217 chemotherapy cycles were administered. Without recombinant human granulocyte colony-stimulating factor (rhG-CSF) support, the MTD1 occurred at the first dose level (docetaxel 75 mg/m2 and mitoxantrone 8 mg/m2); DLTs were febrile neutropenia, grade 4 neutropenia lasting more than 5 days, and grade 3 diarrhea. With prophylactic rhG-CSF, the MTD2 was docetaxel 100 mg/m2 and mitoxantrone 20 mg/m2; DLTs were febrile neutropenia and grade 4 neutropenia. Nine (22%) patients developed neutropenia after the first cycle of treatment. A total of 19 episodes of febrile neutropenia (9% of the cycles) occurred during the whole period of the study; there were no toxic deaths. At high docetaxel (100 mg/m2) and mitoxantrone (> 12 mg/m2) dose levels, a significant decrease of the absolute lymphocyte number was observed; immunophenotyping revealed that all lymphocyte subpopulations were reduced. Grades 2 and 3 neurosensory toxicity occurred in six patients (15%) and one patient (2%), respectively. No cardiac toxicity was observed. Nine complete responses (22%) and 23 partial responses (56%) were achieved (overall response rate, 78%; 95% confidence interval, 62.5% to 88.8%). The median duration of response was 12.5 months, and the median time to tumor progression was 14.5 months. CONCLUSION: The reported combination of docetaxel and mitoxantrone with G-CSF support is a safe, intensified, well-tolerated, and effective regimen as first-line treatment in patients with MBC.

Adult↗

PubMed1998

First-line treatment of advanced nonsmall cell lung carcinoma with docetaxel and vinorelbine.

BACKGROUND: Docetaxel and vinorelbine are active agents in the treatment of nonsmall cell lung carcinoma (NSCLC). The efficacy and toxicity of this combination was evaluated in a Phase II study in patients with advanced NSCLC. METHODS: Forty-six chemotherapy-naive patients (44 men and 2 women with a median age of 64 years) with NSCLC (11 with Stage IIIB and 35 with Stage IV disease) were entered into the study; the World Health Organization (WHO) performance status was 0, 1, and 2 in 32, 11, and 3 patients, respectively. Patients received vinorelbine (25 mg/m2) on Day 1 and docetaxel (100 mg/m2) on Day 2 in cycles repeated every 3 weeks. Granulocyte-colony stimulating factor was given to all patients from Day 3 to Day 10. RESULTS: One hundred and seventy-seven courses of chemotherapy were administered. Adverse events included WHO Grade 4 neutropenia (15 patients), Grade 3/4 thrombocytopenia (3 patients), Grade 3 anemia (2 patients), Grade 2 and 3 neurotoxicity (7 patients and 1 patient, respectively), and Grade 3 fatigue (2 patients). Twenty patients (43%) required hospitalization: 11 (24%) for neutropenic fever (2 deaths from sepsis), and 9 (20%) for nonneutropenic pulmonary infections (2 deaths from cardiopulmonary insufficiency). The median overall survival was 5 months and the 1-year survival was 24%. Four complete responses (9.8%) and 11 partial responses (26.8%) (overall response rate of 36.6%; 95% confidence interval, 21.8-51.3%) were documented in 41 evaluable patients (intent-to-treat: 32.6%). Stable and progressive disease occurred in 13 patients each (31.7%). The median duration of response was 5 months and the median time to progression was 3 months (6 months for the responders). CONCLUSIONS: This schedule of docetaxel and vinorelbine combination is effective but its relatively high incidence of complicated neutropenia precludes its general use in patients with advanced NSCLC.

Adenocarcinoma↗

PubMed1998

Oropharyngeal candidiasis as a marker for esophageal candidiasis in patients with cancer.

The present study was designed to determine the frequency of candidal esophagitis in cancer patients with oral thrush. Patients with clinically and microbiologically diagnosed oral candidiasis were evaluated by endoscopy for concurrent esophageal candidiasis. Esophageal involvement was documented by mucosal lesions, microbiological findings of candidal infection in smears of brushing material, positive cultures of brushing material, and histological evidence of mucosal invasion by the yeast. For 21 of the 22 patients studied, there were endoscopic and microbiological findings of candidal esophagitis. Cultures of the brushing material from all 22 patients were positive, while histological evidence was found for 14 patients. Only 10 of the patients had mild esophageal symptoms. It is concluded that oral thrush represents a reliable marker for esophageal candidiasis in patients with cancer. Routine endoscopy is not necessary to confirm the diagnosis; this procedure should be reserved for patients with persistent thrush and symptoms despite antifungal therapy.

Aged↗

PubMed1998

Salvage chemotherapy with paclitaxel, vinorelbine, and cisplatin (PVC) in anthracycline-resistant advanced breast cancer.

The tolerance and the efficacy of the paclitaxel-vinorelbine-cisplatin combination (PVC regimen) was evaluated in 33 patients with anthracycline-resistant stage IV breast cancer, who had disease progression under anthracycline- or mitoxantrone-based chemotherapy. Fourteen (42%) and 19 (58%) patients had primary and secondary resistance to anthracyclines, respectively; 70% had visceral metastases. Patients received vinorelbine (25 mg/m2) followed by paclitaxel (135 mg/m2) in a 3-hour infusion on day 1, and cisplatin (CDDP; 80 mg/m2) on day 2, in a 3-week schedule. A total of 208 chemotherapy courses were administered (median six courses per patient). Grade 3/4 neutropenia occurred in 13 patients (39%), seven of whom were hospitalized for neutropenic fever (5% of the courses). There was no toxic death. Grade 4 thrombocytopenia occurred in two patients (6%) and grade 3 anemia in three patients (9%). Grade 2 and 3 neurosensory toxicity occurred in 11 patients (32%) and two patients (6%), respectively, and grade 3/4 fatigue was observed in four patients (12%). Two (6%) complete and 17 partial responses (52%) (total, 58%; 95% confidence interval, 42%-75%) were documented. Stable disease was observed in eight patients (24%) and progression in six patients (18%). The median duration of response was 6.5+ months. The median survival was 15+ months, and the 1-year survival was 67%. In conclusion, PVC regimen is an active and well-tolerated salvage chemotherapy in patients resistant to anthracycline.

Adult↗

PubMed1998

Treatment of non-small-cell lung cancer with prolonged oral etoposide.

The efficacy and toxicity of chronic administration of oral etoposide was evaluated in 61 patients with inoperable non-small-cell lung cancer (NSCLC). Ten patients received previous chemotherapy, 15 received radiotherapy, and one received both treatments. Twenty-four patients had concurrent cardiac and/or pulmonary impairment, which precluded more intensive treatment. Etoposide was given orally, 100 mg daily for 7 consecutive days and consequently 100 mg every other day for 14 more days in a 28-day schedule. Partial response was observed in 17 patients (28%; 95% confidence interval, 17-39%) and stable disease in 21 (34%). The median duration of response was 6 months (range, 2-34 months). The median survival for responders was 22 months and that of nonresponders was 7 months (p < 0.001). The median survival for all patients was 9 months (range, 1-35 months; 95% confidence interval, 5.69-12.31%). Toxicity was acceptable. Other than alopecia, which was observed in all patients, myelotoxicity was the most common toxicity--particularly leukopenia, which was severe in nine patients. Other less common toxicities included nausea and vomiting, stomatitis, anorexia, and neurotoxicity and were mild. No treatment-related deaths were observed. In conclusion, the regimen was effective and well tolerated with significant survival benefit for the responders. It represents an interesting therapeutic approach, especially in the elderly.

Administration, Oral↗