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S Rea

Publications and source records attributed to S Rea.

65 records · Page 4Linked to original sources
PubMedDate not supplied

Chemo-immunotherapy in advanced head and neck cancer.

BACKGROUND: Patients with advanced squamous cell carcinoma of the head and neck (SCC) have a depressed immune system whose function is worsened by chemotherapy. In a pilot phase II study, in order to improve the immune function during chemotherapy, we combined to cisplatin (CDDP) and 5-fluorouracil (5-FU) two biological response modifiers, retinyl palmitate (R) and Thymopentin (TP-5) for the treatment of SCC. PATIENTS AND METHODS: Fifty patients with recurrent or metastatic SCC of the head and neck were treated with Cisplatin 24 mg/m2 from day 1 to 5 and 5-FU 1,000 mg/m2 by a 120 hour continuous infusion. Retinyl palmitate was administered orally 50,000 i.u. b.i.d and Thymopentin 50 mg subcutaneously 3 times a week. RESULTS: Chemotherapy treatment was well tolerated with G3 hematological toxicity in 30% of patients and G2 gastrointestinal toxicity in 20% of patients. 16 patients (32%) had a complete response (CR), 13 patients had partial response (PR) (26%), (response rate 58%, 95% c.i. 43%-72%); stable disease (SD) was observed in 7 patients (14%), while 14 patients progressed (PD) (28%). Median time to progression was 12 months (range 2.8-94.5). Median overall survival was 13.5 months (range 2-104). CONCLUSIONS: The association of CDDP and 5-FU with Retinyl Palmitate and TP5 has a major activity in the treatment of advanced head and neck cancer and a relatively well tolerated toxicity.

Adjuvants, Immunologic↗
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Carboplatin, vindesine, 5-fluorouracil-leucovorin and 13-cis retinoic acid in the treatment of advanced non-small cell lung cancer. A phase II study.

PURPOSE: Carboplatin, vindesine and 5-fluorouracil/leucovorin are drugs active in the treatment of non-small cell lung cancer (NSCLC) and they can be administered in an outpatient setting. Retinoids, which are widely used agents in chemoprevention, have been reported to exert (in vitro models) growth inhibitory effects of synergistic type with chemotherapy, and differentiating effects on NSCLC cells. PATIENTS AND METHODS: 28 patients with advanced NSCLC with measurable disease were entered into the trial. Eligibility criteria included performance status < or = 3 and adequate renal and liver function. Patients with brain metastases were not excluded. Treatment was as follows: Carboplatin (CBCDA) 300 mg/m2 day 1, Vindesine (VDS) 3 mg/m2 days 1 and 5, leucovorin (L) 100 mg/m2, 5-fluorouracil (5-FU) 370 mg/m2 for 5 days and 13-cis retinoic acid (R) 1 mg/kg, administered between chemotherapy courses. After 6 courses of chemotherapy responders were maintained with R, until progression. RESULTS: 120 courses of chemotherapy have been delivered (median 4 courses per patient, range 1 to 6). All patients were evaluable for response and toxicity. Objective responses: 2 complete responses (CR) (7%), 9 partial responses (PR) (32%), 9 stable disease (SD) (32%), 8 progressive disease (PD) (29%). (Response rate 39%, 95% CI: 22% to 60%). Median time to progression was 7.7 months (range 3.4-22) and median survival was 9.7 months (range 0.5-27) with 40% of patients alive after one year. Toxicity WHO: hematological grade 3-4 in 46% of patients, grade 2 diarrhea in 21% of patients, ileus in 14% of patients, Neurologic grade 2 in 11% of patients. CONCLUSIONS: The addition of RA to CBDCA, VDS, FU, L, R represents an effective treatment in NSCLC, with manageable toxicity.

Animals↗
PubMedDate not supplied

Cisplatin, vindesine, mitomycin-C and 13-cis retinoic acid in the treatment of advanced non small cell lung cancer. A phase II pilot study.

BACKGROUND: Thirteen-cis retinoic acid (RA) has been shown to have growth-inhibitory and differentiative activity on non-small cell lung cancer (NSCLC) cells in vitro. This promoted the rationale for combining RA with three active drugs, cisplatin (CDDP) vindesine (VDS) and mitomycin-c (MMC) in the treatment of advanced NSCLC. PATIENTS AND METHODS: Patients with a histologically confirmed non-resectable NSCLC, measurable lesion, performance status < or = 3, and informed consent were enrolled. The chemotherapy schedule included cisplatin 60 mg/m2 and mitomycin-c 10 mg/m2 day 1 and vindesine 3 mg/m2 on days 1 and 5, every 4 weeks. RA was administered orally, at a dose of 0.5 mg/kg, 5 days per week, during chemotherapeutic intervals and to responding patients until disease progression was observed. RESULTS: Thirty patients, receiving a total of 163 chemotherapy courses, were evaluated for response and toxicity. Objective responses included complete response in 2 patients (7%), partial response in 10 patients (33%), stable disease in 9 patients (30%) and progressive disease in 9 patients (30%), (response rate 40%: Confidence interval 95% 22.7% to 59.4%). Median time to progression was 8.6 months (range 3.9-45+). Median overall survival was 11.3 months (range 1-45+). The 1-year survival rate was 47%. Toxicity (WHO) included nausea and vomiting grade 2 in 6 patients, transient ileus in 3 patients and grade 3-4 leukopenia in 5 patients. Two patients underwent surgical resection of residual disease and remain in CR. CONCLUSIONS: The addition of RA to cisplatin, vindesine and mitomycin-c is feasible and shows some activity in the treatment of NSCLC, with manageable toxicity.

Adult↗
PubMedDate not supplied

Multicenter phase II study of fractionated bimonthly oxaliplatin with leucovorin and 5-fluorouracil in patients with metastatic colorectal cancer, pre-treated with chemotherapy.

In vitro and in vivo studies have shown that oxaliplatin (L-OHP), 5-fluorouracil (5-FU) and leucovorin (L) have a synergistic activity on metastatic colorectal cancer (MCC). In order to better exploit the synergism of action between the three drugs, L-OHP was administered over 2 days, together with 5-FU-L, in a cohort of patients with MCC that had been pre-treated with chemotherapy. Forty-six patients were entered into the trial. All had been pre-treated with chemotherapy for metastatic disease: 14 with the 'de Gramont' regimen alone, and 32 with the same regimen combined with irinotecan (CPT-11). The outpatient treatment consisted of L-OHP 50 mg/m(2), followed immediately by the 'de Gramont' regimen. All drugs were administered on days 1 and 2, every 14 days. Median patient age was 65 years (range: 46-78), male/female ratio was 29/17. All 46 patients were evaluated for response and toxicity. We observed 1 complete response (2.2%) and 14 partial responses (30.4%), giving an overall response rate of 32.6% (95% CI: 19.5-48.06%); 22 patients had stable disease (47.8%) and 9 patients progressed (19.6%). After a median follow-up of 13 months, median time to progression was 6.4 months (range: 3.1-31.2+), while overall median survival was 12.2 months (range: 3.7-31.2+). Toxicity was manageable: grade 3 or 4 neutropenia was observed in 33% of patients, while only 6% of patients had grade 1-2 neurotoxicity. The fractionated bimonthly schedule of L-OHP plus 5-FU-L, showed activity, with an acceptable toxicity profile, both in patients with MCC pre-treated with the 'de Gramont' regimen alone, or with this regimen associated with CPT-11.

Adenocarcinoma↗
PubMedDate not supplied

Multicenter phase II study of CPT-11 fractionated over two days with bimonthly leucovorin and 5-fluorouracil in patients with metastatic colorectal cancer.

PURPOSE: This multicenter phase II study evaluated the activity and toxicity of the combination of fractionated camptothecin (CPT-11) and 5-fluorouracil/leucovorin (5-FU/LV) (de Gramont regimen) for the treatment of metastatic colorectal cancer (MCC) patients who had received no prior chemotherapy for metastatic disease. PATIENTS AND METHODS: Fifty-four patients with a median age of 63.5 years (range: 43-75), received, every two weeks, a regimen consisting of 2 daily doses of CPT-11, 90 mg/m2 administered over a period of 90 minutes, followed by LV, 200 mg/m2 administered over 2 hours and 5-FU 400 mg/m2 as a bolus and 600 mg/m2 as a 22-hour continuous infusion. Sixty-five percent of patients had synchronous metastatic disease at diagnosis, while 35% of the patients had received adjuvant chemotherapy after radical surgery. RESULTS: All 54 patients, receiving a total of 561 cycles of chemotherapy (median 12 per patient, range 1-26), were assessable for toxicity and response to treatment. The most common toxicities (grade 3-4) among treated patients were as follows: diarrhea in 3 patients, (6%), neutropenia in 9 patients (17%) and asthenia in 3 patients (6%), with no treatment-related death. We observed 4 complete (7.4%) and 18 partial responses (33.3%), giving an overall response rate of 40.7% (95% CI: 28% to 55%); 22 patients had stable disease (40.7%) and 10 patients progressed (18.5%). After a median follow-up of 22 months, the median time to progression was 8.7 months (range 2.3-43.9+), while overall median survival was 18.8 months (range 0.7-43.9+). CONCLUSION: The fractionated bimonthly schedule of CPT-11 plus 5-FU/LV showed a lower gastrointestinal toxicity profile than expected, with substantial activity in patients with MCC.

Adult↗
PubMedDate not supplied

[The current state of adjuvant treatment in carcinoma of the resected colon].

After radical surgery for colo-rectal cancer, the prevention of local recurrence and/or distant metastasis, represents the key factor of the active measures adopted by surgeons and oncologists. Recent trends of the research in this field, show that an effective chemotherapy is the goal to achieve. Our review of the literature on this subject, is aimed to make some remarks about the results of the main randomized protocols of adjuvant chemotherapy conducted in recent years, comparing the efficacy of different treatments. We should consider two ways of administering the chemotherapy: the systemic route, the classic one, and the portal route, especially designed to prevent liver metastasis. At the end of our review, we can conclude the following: poly-chemotherapy (MF or MOF) did not show real advantages compared to 5-FU alone the combination of 5-FU + Levamisole, showed an undoubtable efficacy in Dukes' C colorectal cancer the efficacy of intra-portal vein chemotherapy for Dukes' B colorectal cancer, has been proved in one report only, therefore we are waiting for a confirmative answer from the several similar investigations prompted recently. The analysis of such investigations may contribute, in future, to establish new protocols combining chemotherapy with immunotherapy and particularly, systemic chemotherapy with loco-regional one.

Antineoplastic Combined Chemotherapy Protocols↗
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Phase I-II study of dose intensified chemotherapy with filgrastim and thymopentin in patients with advanced cancer.

BACKGROUND: Carboplatin (CBDCA), cyclophosphamide (CTX) and etoposide (VP-16) combination chemotherapy is active in many tumors. A phase I-II study was designed in order to verify toxicity, maximum tolerated dose and activity of CBDCA, CTX and VP-16 given with Granulocyte Colony Stimulating Factor (G-CSF) and thymopentin (TP5), without bone marrow support. MATERIALS AND METHODS: A group of 12 heavily pretreated patients (PTS), 9 breast cancer, 2 small cell lung cancer and 1 gastric cancer, received fourteen courses of the described combination chemotherapy. Previous treatments were as follows: surgery in 10 PTS, radiotherapy in 7 PTS, chemotherapy in all PTS (median of 9 courses per patient). CBDCA, CTX, VP-16 were given over 3 days. CBDCA doses were calculated and expressed with the area under the concentration versus time curve (AUC). The dose range were as follows: CBDCA AUC 5.5-11 (400-800 mg/m2), CTX 1500-2500 mg/m2, VP-16 450-550 mg/m2, G-CSF was given 5 mg/kg/day from day 4 to day 17. TP5 was given, on alternate days, 1 mg/ kg from day 4 to day 30. RESULTS: 6 PTS developed fever > 38 degrees C for a median (M) duration of 4 days. 4 PTS required platelet support (M of 12 units) and 3 PTS red blood cells support (M of 2 units). Maximum tolerated dose was CBDCA AUC of 8, CTX 2000 mg/m2 and VP16500 mg/m2. No treatment related death occurred. Ten patients had responses and two had disease stabilisation. At the present time 5 PTS are alive and median overall survival is 13 months. CONCLUSIONS: These data indicate that dose intensified CT with the support of G-CSF and TP5 may be delivered safely and shows activity in heavily pre-treated patients.

Breast Neoplasms↗
PubMedDate not supplied

Combined chemotherapy and differentiation therapy in the treatment of advanced non-small-cell lung cancer.

BACKGROUND: In this phase-II pilot study a cisplatin-based treatment was combined with biological agents capable of inducing differentiation in non-small-cell lung cancer (NSCLC) cells with the aim of ameliorating response to chemotherapy. PATIENTS AND METHODS: Forty patients (PTS) with inoperable stage III-B or IV NSCLC were treated with cisplatin (CDDP) 24 mg/m2 on days 1 to 5, 5-fluorouracil (5-FU) 500 mg/m2, by continuous infusion on days 1 to 5 and vindesine (VDS) 3 mg/m2 on days 1 and 5. Beta-interferon (beta-IFN) 1 x 10(6) IU/m2 subcutaneously 3 times a week and retinyl palmitate (R) 50,000 IU orally BID were administered between chemotherapy cycles. Responders were maintained with the same dose of beta-IFN plus R 15,000 IU BID. Half of the PTS had an ECOG performance status of 0-1, 62% of tumours were of squamous histology and 77.5% of PTS had stage IV disease. A median of four courses of chemotherapy per PT was delivered. RESULTS: Forty PTS were evaluable. Seventeen PTS responded, (RR 42%, 95% C.I. 27%-57%). Of the 17 responders 13 had squamous histology. The median response duration was 5.1 months. The median overall survival was 9.1 months. Gastrointestinal toxicity occurred in 58% of PTS, anaemia in 20%, leukopenia in 30%. CONCLUSIONS: The association of CDDP, VDS, 5-FU, beta-IFN and R shows activity in NSCLC, particularly in tumours with squamous histology, with a substantial toxicity.

Aged↗
PubMedDate not supplied

Platinum compounds as radiosensitizers in strontium-89 metabolic radiotherapy.

PURPOSE: Strontium-89 is currently used for the treatment of painful bone metastases. This study reports on two preliminary experiences with low-dose platinum compounds, carboplatin and cisplatin, as radiosensitizers in 89Sr therapy. PATIENTS AND METHODS: 30 patients entered the carboplatin study: 15 patients (Group A) were treated with 148 MBq 89Sr followed by carboplatin (100 mg/m2 at 7 and 21 days) and 15 patients (Group B) were treated with 89Sr alone. 12 patients entered the cisplatin study: six patients (Arm 1) received 148 Mq 89Sr plus cisplatin (50 mg/m2) in two administrations (immediately before and 10 days after 89Sr injection) and six patients (Arm 2) received 89Sr plus two placebo administrations. Pain response was assessed 8 weeks after the therapy on the Wisconsin score modifications. RESULTS: No clinically significant adverse effects or myelosuppression by platinum compounds were observed. In carboplatin study a pain response was observed in 20 of 27 (74%) evaluable patients, 13/15 in group A and 7/12 in group B. The pain response in the patients treated with 89Sr and carboplatin was clearly superior to that seen in the patients treated with 89Sr alone (P = 0.025), whereas survival was only marginally better in the combined treatment group (8.1 vs 5.7 months, P = 0.19). In cisplatin study a pain response was observed in 10 of 12 (83%) evaluable patients, 5/6 in Arm 1 and 4/6 in Arm 2. CONCLUSIONS: Low-dose platinum compounds seem to enhance the effects of 89Sr radioisotope therapy on pain from bone metastases without relevant hematological toxicity.

Bone Neoplasms↗
PubMedDate not supplied

Beta-interferon, retinoids and tamoxifen combination in advanced breast cancer.

PURPOSE: To investigate, in patients with metastatic breast cancer (MBC), a combination of retinoids, beta-interferon (beta-IFN) and tamoxifen (TAM). PATIENTS AND METHODS: This trial was conducted from January 1987 to June 1992 in 85 consecutive patients with MBC. All patients had been treated for metastatic disease: 43 patients received chemotherapy, 35 received hormone therapy and 7 received both. Forty-nine patients, with a better prognosis, and a longer disease-free survival (DFS) were treated with beta-IFN 1 x 10(6) IU/m2 subcutaneously three times a week, TAM 10 mg TID, retinyl palmitate (R) 50,000 IU BID. Thirty-six patients with shorter DFS, were first treated with 8 courses of chemotherapy followed, in responders, by beta-IFN, R and TAM. RESULTS: With a median follow-up of 7 years (minimum 4 years) 59% of 85 evaluable patients responded, 20% had stabilization of disease and 21% progressed. Median response duration was 43 months. Median survival was 28 months and 25% of patients were alive after 9 years. Toxicity of biological therapy was moderate. CONCLUSIONS: Our data show that beta-IFN, TAM and R combination is effective as salvage therapy in patients with MBC.

Adult↗