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1.
Am J Clin Oncol ; 23(5): 481-6, 2000 Oct.
Article in English | MEDLINE | ID: mdl-11039508

ABSTRACT

A phase II trial was performed to assess the efficacy and toxicity of a combination of ifosfamide (IFX), cisplatin (CDDP), and vinorelbine (VNB) as neoadjuvant chemotherapy (NAC) for untreated advanced cervical carcinoma (ACC). Between October 1995 and February 1998, 40 patients were entered in this study. Their median age was 43 years (range: 23-74 years). International Federation of Gynecology and Obstetrics stages were: IIB, 23; IIIB, 13; and IVA, 4. Therapy consisted of: IFX 2,000 mg/m2 1-hour (H) IV infusion days 1 to 3; 2-mercaptoethanesulfonic acid sodium salt (mesna) 400 mg/m2 IV bolus H 0 and 4, and 800 mg/m2 by mouth H 8, days 1 to 3; VNB 25 mg/m2 20-minute IV infusion days 1 and 8; and CDDP 75 mg/m2 IV day 3. Cycles were repeated every 28 days for a total of three courses. Both staging and response (R) assessment were performed by a multidisciplinary team. An objective response (OR) was observed in 24 of 40 patients (60%; 95% confidence interval, 45-75%). Four patients achieved complete response (CR) (10%); 20 partial response (50%); 12 patients stable disease (30%); and 4 progressive disease (10%). Eight of 24 patients (33%) with OR underwent radical surgery, and histologic CRs were recorded in 2 of them. The remaining patients received definitive radiotherapy after NAC. The dose-limiting toxicity was myelosuppression. Leukopenia occurred in 32 patients (80%) and was grade III or IV in 14 patients (36%). Peripheral neuropathy occurred in 9 patients (22%), whereas myalgias occurred in 10 (25%). Constipation was observed in 9 patients (23%); emesis occurred in 35 patients (88%). There were no therapy-related deaths. These results indicate that IFX/CDDP/VNB is an active combination for ACC with moderate toxicity. Implementation of this regimen in a multimodal therapy protocol deserves further study.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Carcinoma, Squamous Cell/drug therapy , Uterine Cervical Neoplasms/drug therapy , Adult , Aged , Antineoplastic Combined Chemotherapy Protocols/administration & dosage , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Carcinoma, Squamous Cell/pathology , Cisplatin/administration & dosage , Female , Humans , Ifosfamide/administration & dosage , Mesna/administration & dosage , Middle Aged , Neoadjuvant Therapy , Neoplasm Staging , Survival Analysis , Uterine Cervical Neoplasms/pathology , Vinblastine/administration & dosage
2.
J Clin Oncol ; 15(2): 604-9, 1997 Feb.
Article in English | MEDLINE | ID: mdl-9053483

ABSTRACT

PURPOSE: To evaluate the efficacy and toxicity of vinorelbine (VNB) as single-agent neoadjuvant chemotherapy in advanced cervical carcinoma (ACC). PATIENTS AND METHODS: Between December 1993 and October 1995, 43 untreated patients with stages IIB to IVA squamous cell cervical cancer were entered onto this study. Forty-two patients are assessable for response and 43 for toxicity. The median age was 46 years (range, 28 to 65). Distribution by stages (International Federation of Gynecology and Obstetrics [FIGO]) was as follows: IIB, 18 patients; IIIA, one; IIIB, 19; and IVA, five. Therapy consisted of VNB 30 mg/m2 by 20-minute intravenous (IV) infusion repeated weekly for 12 injections and followed by radical surgery if feasible or definitive radiotherapy. Both staging and response assessment were performed by a multidisciplinary team. RESULTS: One patient was considered not assessable for response. A total of 493 cycles of therapy were administered and objective remissions were observed in 19 of 42 patients (45%; 95% confidence interval, 30% to 60%). Two patients (5%) had a complete response (CR) and 17 (40%) a partial response (PR); no change (NC) was observed in 16 (38%) and progressive disease (PD) in seven (17%). Six of 19 patients (32%) who achieved objective responses (ORs) underwent surgery. The median time to failure and median survival time have not been reached yet. There were no therapy-related deaths. The dose-limiting toxicity was myelosuppression. Leukopenia occurred in 35 patients (81%) and was grade 3 or 4 in seven (17%). Twelve patients (28%) developed peripheral neuropathy, while myalgias occurred in 10 (23%). Constipation was observed in nine patients (21%), one with a prolonged ileum. Phlebitis was recorded in 18 patients (41%). In contrast, emesis and mucositis were rarely observed. No patient developed alopecia grade 3. By the end of the twelfth course of treatment, the average received dose-intensity was 85.4% of that projected. CONCLUSION: VNB is an active drug against ACC with moderate toxicity. Its activity is among the highest reported for single agents. Further evaluation in association with other agents is clearly justified.


Subject(s)
Antineoplastic Agents, Phytogenic/therapeutic use , Carcinoma, Squamous Cell/drug therapy , Uterine Cervical Neoplasms/drug therapy , Vinblastine/analogs & derivatives , Adult , Antineoplastic Agents, Phytogenic/administration & dosage , Antineoplastic Agents, Phytogenic/adverse effects , Carcinoma, Squamous Cell/pathology , Carcinoma, Squamous Cell/radiotherapy , Carcinoma, Squamous Cell/surgery , Chemotherapy, Adjuvant , Disease Progression , Drug Administration Schedule , Female , Humans , Infusions, Intravenous , Middle Aged , Neoplasm Staging , Treatment Outcome , Uterine Cervical Neoplasms/pathology , Uterine Cervical Neoplasms/radiotherapy , Uterine Cervical Neoplasms/surgery , Vinblastine/administration & dosage , Vinblastine/adverse effects , Vinblastine/therapeutic use , Vinorelbine
3.
Am J Clin Oncol ; 19(2): 132-5, 1996 Apr.
Article in English | MEDLINE | ID: mdl-8610635

ABSTRACT

A phase II trial was performed to evaluate the efficacy and toxicity of a combination of cisplatin (CDDP) and ifosfamide (IFX) as neoadjuvant chemotherapy in advanced cervical carcinoma (ACC). Between August 1991 and September 1993, 57 untreated patients with stages IIB to IVA were entered into this study. Median age was 44 years (range, 25 to 74 years). The distribution by stages (International Federation of Gynecology and Obstetrics) was as follows: IIB, 31 patients; IIIB, 21 patients; and IVA, 5 patients. Therapy consisted of IFX 2000 mg/m(2) 1-h i.v. infusion days 1 to 3; mesna 400 mg/m(2) i.v. bolus at hours 0 and 4, and 800 mg p.o. at hour 8; and CDDP 100 mg/m(2) on day 3. Cycles were repeated every 28 days for a total of three courses. Both staging and response assessment were performed by a multidisciplinary team. An objective response was observed in 30 of 56 patients (54%; 95% confidence interval, 41 to 67%). Four patients (7%) had a complete response (CR) and 26(46%) had a partial response (PR). Patients with CR or operable PR underwent surgery, otherwise received definitive radiotherapy. Toxicity was mild to moderate. There were no toxicity related deaths. These results indicate that IFX/CDDP is an active combination for ACC with mild toxicity. The results of phase III studies that evaluate the real impact of neoadjuvant chemotherapy are awaited.


Subject(s)
Antineoplastic Agents, Alkylating/administration & dosage , Antineoplastic Agents/administration & dosage , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Carcinoma/drug therapy , Cisplatin/administration & dosage , Ifosfamide/administration & dosage , Uterine Cervical Neoplasms/drug therapy , Adult , Aged , Antineoplastic Agents/adverse effects , Antineoplastic Agents, Alkylating/adverse effects , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Carcinoma/pathology , Carcinoma/surgery , Chemotherapy, Adjuvant , Cisplatin/adverse effects , Female , Follow-Up Studies , Humans , Ifosfamide/adverse effects , Mesna/therapeutic use , Middle Aged , Neoplasm Staging , Prospective Studies , Radiotherapy, Adjuvant , Remission Induction , Survival Rate , Uterine Cervical Neoplasms/pathology , Uterine Cervical Neoplasms/surgery
4.
Obstet Gynecol ; 78(4): 685-8, 1991 Oct.
Article in English | MEDLINE | ID: mdl-1717907

ABSTRACT

Between October 1986 and August 1988, 33 previously untreated patients with locally advanced cervical carcinoma were studied to evaluate the efficacy and toxicity of a neoadjuvant chemotherapy combination consisting of cisplatin 50 mg/m2 intravenously (IV) on day 1, vincristine 1.4 mg/m2 IV on day 1, and bleomycin 25 mg/m2 IV in a 6-hour infusion on days 1-3. Cycles were repeated every 10 days for a total of three cycles, after which definitive radiation therapy (external and intracavitary) was administered. The median age was 47 years, and distribution by stages (International Federation of Gynecology and Obstetrics) was as follows: IIB, 12 subjects; IIIB, 19; and IVA, two. A multidisciplinary team conducted both staging and assessment of response to induction chemotherapy before the beginning of radiotherapy. Thirty-one women were fully evaluable for response and toxicity. No complete response was observed; seven subjects (23%) experienced a partial response, 18 (58%) had no change, and six (19%) showed progressive disease. Toxicity was mild to moderate and included nausea and vomiting, alopecia, hyperthermia, peripheral neurotoxicity, and anemia. We conclude that this regimen at this dosage and time interval produced a low number of objective regressions with a significant progression rate and is of doubtful value as neoadjuvant chemotherapy.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Carcinoma, Squamous Cell/drug therapy , Uterine Cervical Neoplasms/drug therapy , Adult , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Bleomycin/administration & dosage , Cisplatin/administration & dosage , Combined Modality Therapy , Female , Follow-Up Studies , Humans , Middle Aged , Vincristine/administration & dosage
5.
Medicina [B.Aires] ; 47(5): 471-6, sept.-oct. 1987. Tab, ilus
Article in Spanish | BINACIS | ID: bin-30186

ABSTRACT

Se llevó a cabo un análisis retrospectivo para conocer la dimensión real de las enfermedades neoplásicas en la Provincia de Neuquén, en el período 1980-1984. Se observó que la mortalidad por cáncer, con una tasa de 71,2/100 000 habitantes en 1970, se incrementó a 85,3/100 000 en 1983 y en el análisis porcentual para las distintas causas mostró un incremento del 6,8 al 15,7%. La morbilidad por cáncer del Hospital Provincial Neuquén, desprendida del análisis de 1061 protocolos de pacientes con cáncer, mostró una frecuencia de 51,2% en el sexo femenino y 49,8% en el masculino. La edad promedio fue de 49 en el sexo femenino y 53,4 años en el masculino. El análisis de la morbilidad por cáncer mostró una peculiar distribución de las localizaciones en ambos sexos con neto predominio del cáncer de cuello uterino en las mujeres (23,7%) y estómago en los varones (17,8%). Se registró una alta frecuencia de neoplasias de origen hematológico en ambos sexos, especialmente linfomas en el sexo masculino (cercano al 10%) (AU)


Subject(s)
Middle Aged , Humans , Male , Female , Neoplasms/epidemiology , Neoplasms/mortality , Epidemiology, Descriptive/trends , Retrospective Studies , Argentina , Brazil
6.
Medicina (B.Aires) ; 47(5): 471-6, sept.-oct. 1987. tab, ilus
Article in Spanish | LILACS | ID: lil-59156

ABSTRACT

Se llevó a cabo un análisis retrospectivo para conocer la dimensión real de las enfermedades neoplásicas en la Provincia de Neuquén, en el período 1980-1984. Se observó que la mortalidad por cáncer, con una tasa de 71,2/100 000 habitantes en 1970, se incrementó a 85,3/100 000 en 1983 y en el análisis porcentual para las distintas causas mostró un incremento del 6,8 al 15,7%. La morbilidad por cáncer del Hospital Provincial Neuquén, desprendida del análisis de 1061 protocolos de pacientes con cáncer, mostró una frecuencia de 51,2% en el sexo femenino y 49,8% en el masculino. La edad promedio fue de 49 en el sexo femenino y 53,4 años en el masculino. El análisis de la morbilidad por cáncer mostró una peculiar distribución de las localizaciones en ambos sexos con neto predominio del cáncer de cuello uterino en las mujeres (23,7%) y estómago en los varones (17,8%). Se registró una alta frecuencia de neoplasias de origen hematológico en ambos sexos, especialmente linfomas en el sexo masculino (cercano al 10%)


Subject(s)
Middle Aged , Humans , Male , Female , Neoplasms/epidemiology , Argentina , Brazil , Epidemiology, Descriptive/trends , Neoplasms/mortality , Retrospective Studies
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