Adjuvant chemotherapy with cisplatin, etoposide, fluorouracil and leucovorin for gastric carcinoma.

PURPOSE: The aim of this study was to evaluate the efficacy of cisplatin, etoposide, 5-fluorouracil (5-FU), and leucovorin (L; CEFL) combination chemotherapy given as adjuvant treatment to patients with stage III gastric cancer. PATIENTS AND METHODS: A total of 33 patients who had undergone curative resection for stage III gastric adenocarcinoma were enrolled in our adjuvant chemotherapy protocol to receive 6 cycles of CEFL starting within 8 weeks from surgery. CEFL consisted of cisplatin 30 mg/m2 on days 1-3; 5-FU 300 mg/m2 continuous infusion on days 1-3; and etoposide 90 mg/m2 on days 1-3. Cycles were repeated every 4 weeks. Relapse-free survival (RFS) and overall survival (OS) were estimated using Kaplan-Meier method. Comparison between groups was carried out using log-rank test. RESULTS: Treatment was completed by 30 (91%) patients. After a mean follow-up of 31 months 15 (50%) patients have relapsed. Mean RFS was 31 months (range 6 to 114+). Patients with stage IIIA disease had longer RFS that those with stage IIIB (37 vs. 25 months, p>0.05). Mean OS was 35 months (range 4 to 114+), while stage IIIA patients survived longer than IIIB ones (42 vs. 27 months, p>0.05). Principal side effects of therapy were from the bone marrow and the gastrointestinal tract. There were 2 treatment-related deaths due to neutropenic sepsis. CONCLUSION: CEFL regimen appears to be an effective adjuvant treatment for patients with stage III gastric carcinoma as it prolongs both RFS and OS. However, its pronounced myelotoxicity requires the prophylactic use of granulocyte colony stimulating factor (G-CSF).

Second line chemotherapy with methotrexate and gemcitabine in patients with relapsing head and neck cancer.

PURPOSE: The aim of this study was to evaluate the efficacy and toxicity profile of the combination of methotrexate and gemcitabine given as second-line treatment in patients with relapsing and/or metastatic head and neck cancer (HNC). PATIENTS AND METHODS: A total of 21 patients with HNC who had relapsed after first-line treatment with cisplatin-containing regimens were enrolles. Treatment consisted of intravenous (i.v.) administration of methotrexate 30 mg/m(2) and gemcitabine 800 mg/m(2) on days 1, 8, and 15 in cycles of 28 days. Primary sites included the larynx, tongue, nasopharynx, hypopharynx, nasal cavity, and parotid gland. The study end point was the evaluation of treatment efficacy and toxicity. RESULTS: Seven (33%) patients received only 1 or 2 cycles and discontinued treatment because of disease progression. Among 14 patients evaluable for respone, 1 complete (CR) and 2 partial responses (PR) were observed, yielding a response rate of 21.4%. The patient with CR remains relapse-free for 74(+) months. The 2 PR patients relapsed after 14 and 25 months and are still alive at 18 and 32 months, respectively. Seven patients showed minor response (MR) or stable disease (SD) with symptomatic relief lasting 4-12 months (mean 8). All but 2 of adequately treated patients (12/14 or 85.7%) attained a clinical benefit response (CBR). Mean time to progression (TTP) of all patients was 8 months (range 1-74(+)), while mean overall survival (OS) was 14 months (range 1-74(+)). Toxicity was mild to moderate and easily manageable. CONCLUSION: Methotrexate and gemcitabine combination is an effective second-line treatment for patients with relapsing and/or metastatic HNC. Moreover, this regimen is well tolerated with mild to moderate, easy to treat, toxicity.

Correlation of tissue transglutaminase expression on breast cancer tissue with time to relapse, overall survival, and clinical and molecular prognostic factors: a preliminary report.

PURPOSE: To correlate tissue transglutaminase (TTG) expression with the expression of molecules with prognostic significance in breast cancer patients and with classical clinical parameters (disease stage, histological grade, overall survival (OS), relapse rate, disease progression and time to treatment failure-TTF). PATIENTS AND METHODS: Paraffin-embedded tissue specimens from 68 breast cancer patients were studied retrospectively for TTG expression, estrogen (ER) and progesterone (PG) receptors, c-erbB-2, p53, Bcl-2, and Ki-67. Sixty-seven patients were females (mean age 60.5 years). Histology was ductal carcinoma in 53 (inflammatory in 2 and mucinous in 1 of them), lobular in 13 and tubular in 2 cases. Grade was 1 and 2 in 45 cases and 3 in 23. Forty-six patients had early-stage disease (I - IIB) and 22 advanced (IIIA - IV). RESULTS: Fifty patients had at least 1 favorable molecular prognostic factor while all but 3 had at least 1 unfavorable prognostic factor. Twenty-nine (42.6%) patients have relapsed so far (mean TTF 31.4 months). Fifty-two (76.5%) patients are still alive (mean OS 38.5 months). Of the 59 patients with nodal and/or metastatic disease 54 were expressing TTG and 32 Bcl-2. Five were not expressing either one while 22 were expressing both. Of the 9 patients without nodal and/or metastatic disease all but one were expressing TTG and Bcl-2. Analyzing these subgroups of patients there was sufficient evidence that TTG expression was correlated with a trend for prolonged survival both in patients with localized and extensive disease, while the coexpression with Bcl-2 was correlated with a trend for prolongation of TTF and OS, both in relapsing and nonrelapsing patients. However, these differences did not reach statistical significance. Similar comparisons of TTG expression with the presence of adverse prognostic factors verified a beneficial effect of TTG expression on OS in all subgroups. CONCLUSION: Our data suggest that TTG is an independent favorable prognostic factor for survival, possibly enhancing the apoptotic effect of chemotherapy.

Sequential chemoradiotherapy with docetaxel, cisplatin, and 5-fluorouracil in patients with locally advanced head and neck cancer.

The purpose of this phase II trial was to evaluate the toxicity of a sequential chemoradiotherapy approach using docetaxel, cisplatin, and 5-fluorouracil (5-FU) (DCF) with granulocyte colony-stimulating factor support in previously untreated patients with locally advanced head and neck cancer (HNC). Secondary endpoints included preliminary assessment of response. Patients with locally advanced HNC, a World Health Organization performance status 0 to 2, and no prior history of chemotherapy or radiotherapy were included. Treatment consisted of docetaxel 80 mg/m2 (1-hour infusion) on day 1, cisplatin 40 mg/m2 (1-hour infusion) on days 2 and 3, and 5-fluorouracil 1,000 mg/m2 (24-hour continuous infusion), on days 1 to 3, repeated every 28 days for a maximum of 4 cycles per patient. All patients received granulocyte colony stimulating factors subcutaneously between days 4 and 9. Radiation therapy (RT) to the primary tumor site and neck lymph nodes was planned within 5 weeks of the last cycle of chemotherapy. The primary tumor site received 60 to 70 Gy. Twenty patients (median age 56 years, range: 40-72 years) received a total of 60 cycles of DCF. The median number of cycles was 3 (range: 1-4 cycles). All patients were evaluable for toxicity and response. The most common acute nonhematologic toxicities from DCF induction chemotherapy included alopecia, mucositis, peripheral sensory neuropathy, onycholysis, and asthenia. Febrile neutropenia developed in two patients and grade IV diarrhea in one patient. There were no treatment-related deaths. The overall response rate (RR) after DCF induction chemotherapy was 90% (95% confidence interval [CI]: 76.8-103.1%). After the completion of RT, the overall RR was 95% with a complete response rate of 73% (95% CI: 49.9-90.1%). Organ preservation was achieved in eight patients with laryngeal cancer and one patient with base of tongue involvement. After a median follow-up of 36 months (range: 5-43 months) the median disease-free and overall survival have not been reached yet. The 1- and 2-year survival rates were 85% and 60%, respectively. Sequential chemoradiotherapy with DCF and growth factor support is feasible and very active, with durable responses in patients with locally advanced head and neck cancer. Further evaluation of this modality is justified in the context of a clinical trial.

Combination chemotherapy with docetaxel, cisplatin, and 5-fluorouracil in previously treated patients with advanced/recurrent head and neck cancer: a phase II feasibility study.

The purpose of this phase II feasibility trial was to determine the efficacy and toxicity of docetaxel combined with cisplatin and 5-fluorouracil in patients with locally advanced and/or recurrent squamous cell carcinoma of the head and neck. Nineteen patients entered the study. The majority had received prior radiotherapy but were chemotherapy naive. Treatment consisted of docetaxel 80 mg/m2 day 1, cisplatin 40 mg/m2 days 2 and 3, and 5-fluorouracil 1,000 mg/m2 by continuous infusion days 1 to 3. The cycle was repeated every 28 days. Most patients received granulocyte colony-stimulating factor, 150 microg/m2/day subcutaneously between days 4 and 8. The median number of chemotherapy cycles per patient was four. Dose reduction was done in three patients with no treatment delays. Of the 16 evaluable for response, seven patients (44%) demonstrated an objective response, including two complete and five partial ones; eight patients (50%) had stable disease; and one patient had progressive disease. The median time to progression was 7.5 months (range: 4-17.5 months). The median survival was 11 months (range: 1-18 months) and 1-year survival was 49%. Febrile neutropenia was recorded in 15% of courses. There were no toxic deaths. In conclusion, the combination of docetaxel, cisplatin, and 5-fluorouracil is an active regimen against previously treated squamous cell carcinoma of the head and neck with acceptable toxicity.

[Laser treatment of detachments of the retinal pigment epithelium associated with sub-retinal neovascularization in the context of age-related macular degeneration: retrospective study]. / Traitement au laser des décollements de l'épithélium pigmentaire rétinien associes à des néovaisseaux sous-rétiniens dans le cadre de la degenerescence maculaire liée à l'âgè: étude rétrospective.

Pigment Epithelial Detachment (PED) associated with subretinal new vessels (SRNV) is a particular aspect of Age Related Macular Degeneration (ARMD). We retrospectively analysed the results of dye laser photocoagulation in 63 eyes of 56 patients with vascularised PED. We photocoagulated in a confluent manner the presumed zones of SRNV, detected by fluorescein angiography and three-mirrors-lens examination. In most cases, the SRNV were of the occult type. In 89% of the treated eyes we obtained a flattening of the PED and the visual acuity was stabilized or ameliorated in 66% of the cases after a mean follow up of 29 months. This final visual acuity was better or equal to 1/10 in 64% of the cases and superior or equal to 5/10 in 46% of the cases. Subfoveal SRNV, initial visual acuity of less than 1/10, and persistence or recurrence of the PED after treatment were of bad prognosis. However, recurrence of the SRNV was not necessarily of bad prognosis if it could be retreated. Treatment of interpapillomacular SRNV had the best prognosis. Laser photocoagulation can be beneficial in well selected patients with vascularised PED.

Adaptation of two different calcium hydroxide bases under a composite restoration.

A preliminary scanning electron microscope (SEM) study was carried out to investigate how the adaptation of two calcium hydroxide bases (one chemically cured, one light cured) was affected by the polymerization contraction of a supervening light-cured composite resin restoration. Occlusal cavities were prepared in 40 sound extracted human premolars, divided into two equal groups. In the first group a chemically cured calcium hydroxide (Dycal, De Trey Dentsply, Konstanz, FRG) was placed as a base. In the second group a new light-cured calcium hydroxide product (Prisma VLC Dycal, De Trey Dentsply) was used. The restorations were completed with an acid-etched, incrementally placed composite resin. The specimens were sectioned vertically and debrided. A replica was made of each half-tooth. The interfaces between composite resin/base and base/dentine were viewed and photographed in the SEM. The marginal adaptation at these two interfaces was classified into three categories according to the extent of the gaps that were observed. Prisma VLC Dycal base was found to be pulled away from the dentine floor of the cavity as a result of an apparent adhesion to the composite resin during polymerization contraction. Dycal was better adapted to the cavity floor than Prisma VLC Dycal. Disorganization of the resin-bonded Prisma VLC Dycal was minimal even after acid etching the enamel, sectioning and ultrasonic debridement. Dycal appeared to be more friable, and occasionally exhibited marked disorganization as a result of these procedures.

Seasonal variations in the frequency distribution of breast cancer in Greek women according to the month of their birth.

The frequency distribution of patients with breast cancer according to the month of their birth was examined in 1,165 women comprising the total number of patients recorded in our cancer registry from 1975 until the end of 1982. Statistical evaluation of this material using an exact chi 2 for simple null hypothesis demonstrated the existence of two high frequency peaks corresponding to March and April in the spring and September in the autumn. These frequencies were significantly higher (P less than 0.001) than those of the remaining months. Confirmation of this finding would imply the introduction of a new variant in breast cancer epidemiology.