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P Chomy

Publications and source records attributed to P Chomy.

At least 19 recordsLinked to original sources
PubMed2002

Patterns of failure after prophylactic cranial irradiation in small-cell lung cancer: analysis of 505 randomized patients.

BACKGROUND: Prophylactic cranial irradiation (PCI) has a beneficial effect on overall survival in patients with small-cell lung cancer (SCLC) in complete remission as shown in a worldwide meta-analysis. The current analysis aimed to evaluate PCI effects on patterns of failure in this patient category. PATIENTS AND METHODS: The Institut Gustave-Roussy coordinated two parallel randomized studies including a total of 511 patients with SCLC. Patients were randomly assigned to either PCI (24 Gy in eight fractions and 12 days) or no PCI. Patterns of failure were analyzed according to (i) total event rates and (ii) isolated first site of relapse using a competing risk approach. RESULTS: Five hundred and five patients were analyzed. The 5-year cumulative rate of brain metastasis as an isolated first site of relapse was 37% in the control group and 20% in the PCI group (P < 0.001). The overall 5-year rates of brain metastasis were 59% and 43%, respectively [relative risk (RR) 0.50; P < 0.001]. The 5-year overall survival rates were 15% in the control group and 18% in the PCI group (RR 0.84; P = 0.06). CONCLUSIONS: PCI decreased significantly the risk of brain metastasis. Other events were not influenced. The relative death risk reduction was of borderline significance. Results reported as isolated first cause of failure and subsequent competing events may explain why a major treatment effect on brain metastases rate has a rather moderate effect on survival.

Adult↗
PubMed1998

Ifosfamide and gemcitabine: a phase II trial in advanced inoperable non-small cell lung cancer.

The novel nucleoside agent gemcitabine has demonstrated antitumor activity against a variety of solid tumors and is associated with low toxicity. A phase I trial in Germany of gemcitabine combined with the alkylating agent ifosfamide has shown encouraging activity against non-small cell lung cancer. The efficacy and toxicity of this combination was further evaluated in a phase II trial involving chemotherapy-naive patients with non-small cell lung cancer (mostly stage IV disease). Gemcitabine was administered at a dose of 1,000 mg/m2 on days 1, 8, and 15, followed by a 1-week rest, while ifosfamide was given at a dose of 1,500 mg/m2 on days 8 through 12. Fifty-five patients were treated, 49 of whom are evaluable for response. Six patients were not evaluable because they had not received sufficient therapy (less than one complete cycle) because of early disease progression or early death. Twelve patients responded, for an overall objective response rate of 24.5%. The median survival time was 8.9 months, and the 1-year survival rate was 30.9%. Grades 3 and 4 neutropenia occurred in 30.2% and 24.5% of patients, respectively, but the incidence of infection was low. These results indicate that the combination of gemcitabine and ifosfamide is active against non-small cell lung cancer and has a mild toxicity profile, and suggest that further evaluation of this combination is warranted.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1997

Dose-intensity of a four-drug chemotherapy regimen with or without recombinant human granulocyte-macrophage colony-stimulating factor in extensive-stage small-cell lung cancer: a multicenter randomized phase III study.

PURPOSE AND METHODS: We investigated whether a high-dose chemotherapy regimen of cyclophosphamide 1,800 mg/m2, 4'-epidoxorubicin 60 mg/m2, etoposide 330 mg/m2, and cisplatin 120 mg/m2 given monthly for four cycles with recombinant human granulocyte-macrophage colony-stimulating factor (rhGM-CSF) support (5 micrograms/kg daily for 10 days) could improve the survival of patients with extensive-stage small-cell lung cancer (SCLC) compared with a standard-dose regimen (cyclophosphamide 1,200 mg/m2, 4'-epidoxorubicin 40 mg/m2, etoposide 225 mg/m2, and cisplatin 100 mg/m2) given monthly for six cycles. Planned cumulative doses of the drugs were the same in both treatment arms except for cisplatin (which was 80% in the higher-dose plus rhGM-CSF group). RESULTS: At the time of the preplanned interim analysis, 125 patients, 60 in the standard-dose group and 65 in the higher-dose plus rhGM-CSF group, had entered the study; 116 were eligible, 55 in the standard-dose group and 61 in the higher-dose group. All patients were included in the analyses. The cumulative doses of each drug actually delivered were significantly higher in the standard-dose group. No difference in response rates was observed between the two groups. There were significantly greater hematologic toxicities, documented infections, and transfusions of RBCs and platelets in the higher-dose plus rhGM-CSF group. Patients in this group proved to have a shorter survival duration and a shorter time to relapse than patients in the standard-dose group (median overall survival: standard-dose, 10.8 months; higher-dose, 8.9 months; log-rank test with adjustment for prognostic variables, P = .0005; respective probabilities of relapse at 1 year, 77 +/- 0.6 and 96 +/- 2.2; log-rank test, P = .013). CONCLUSION: A 50% increase in dose-intensity for this four-drug regimen could not be achieved with GM-CSF due to excessive toxicity in patients with extensive-stage SCLC.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1997

A phase II trial of gemcitabine and ifosfamide in non-small cell lung cancer.

The novel nucleoside agent gemcitabine has demonstrated antitumor activity against a variety of solid tumors and is associated with low toxicity. A phase I trial in Germany of gemcitabine combined with the alkylating agent ifosfamide has shown encouraging activity against non-small cell lung cancer (NSCLC). The efficacy and toxicity of this combination was further evaluated in a phase II trial of chemotherapy-naive patients with NSCLC (mostly stage IV disease). Gemcitabine was administered at a dose of 1,000 mg/m2 on days 1, 8, and 15 followed by a 1-week rest, while ifosfamide was given at a dose of 1,500 mg/m2 on day 8 and days 9 through 12. Fifty-one of 56 patients were evaluable for response. Eleven partial responses were seen, for an overall objective response rate of 22%. The 6- and 9-month survival rates are 62% and 41%, respectively. Grade 3 and 4 neutropenia occurred in 35.8% and 24.5% of patients, respectively, but the incidence of infection was low. These results indicate that the combination of gemcitabine and ifosfamide is active against NSCLC and has a mild toxicity profile, and suggest that further evaluation of this combination is warranted.

Adult↗
PubMed1996

[Results of a randomized study comparing combination of navelbine-cisplatin to combination of vindesine-cisplatin and to navelbine alone in 612 patients with inoperable non-small cell lung cancer].

The combination of vindesine and cisplatin is considered a reference regimen in advanced NSCLC which has yielded a significant improvement in the duration of survival. A phase II study of a new semi-synthetic vinca alkaloid, Navelbine, reported an unusually high 29% response rate in stage III-IV NSCLC and a phase I-II study established the feasibility of the combination of Navelbine and cisplatin. We, therefore, designed a prospective randomized trial to compare Navelbine and cisplatin (NVB-P) to vindesine and cisplatin (VDS-P) and to evaluate whether the best of these regimens affords a survival benefit compared to Navelbine alone (NVB), an outpatient regimen. Forty-five centers included 612 patients in this study: 206 in NVB-P, 200 in VDS-P and 206 in NVB. Navelbine was given at a dose of 30 mg/m2 weekly, cisplatin at 120 mg/m2 on day 1, day 29 and then every 6 weeks and vindesine at 3 mg/m2 weekly for 6 weeks and then every other week. Treatment was continued until progression or toxicity. Patients' characteristics were similar in the three groups with 59% of patients presenting with metastatic disease. An objective response rate was observed in 30% of patients in NVB-P versus 19% in VDS-P (P = .02) and 14% in NVB (P < .001). The median duration of survival was 40 weeks in NVB-P compared to 32 weeks in VDS-P and 31 weeks in NVB. The comparison of survival between the three groups demonstrated an advantage for NVB-P compared to VDS-P (P = .04) and NVB (P = .02). Neutropenia was significantly higher in the NVB-P group (P < .001) and neurotoxicity more frequent with VDS-P (P < .004). Since our results have demonstrated that NVB-P yields a longer survival duration and a higher response rate than VDS-P or NVB alone, with acceptable toxicity, this combination should be considered a reference regimen in advanced NSCLC.

Adult↗
PubMed1995

Prophylactic cranial irradiation for patients with small-cell lung cancer in complete remission.

BACKGROUND: Prophylactic cranial irradiation in patients with small-cell lung cancer decreases the overall rate of brain metastases without an effect on overall survival. It has been suggested that this treatment may increase neuropsychological syndromes and brain abnormalities indicated by computed tomography scans. However, other retrospective data suggested a beneficial effect on overall survival for patients in complete remission. PURPOSE: Our purpose was to evaluate the effects of prophylactic cranial irradiation on brain metastasis, overall survival, and late-occurring toxic effects in patients with small-cell lung cancer in complete remission. METHODS: We conducted a prospective study of 300 patients who had small-cell lung cancer that was in complete remission. The patients were randomly assigned to receive either prophylactic cranial irradiation delivering 24 Gy in eight fractions during 12 days (treatment group) or no prophylactic cranial irradiation (control group). A neuropsychological examination and a computed tomography scan of the brain were performed at the time of random assignment and repeatedly assessed at 6, 18, 30, and 48 months. Patterns of failure were analyzed according to total event rates and also according to an isolated first site of relapse, using a competing-risk approach. RESULTS: Two hundred ninety-four patients who did not have brain metastases at the time of random assignment were analyzed. The 2-year cumulative rate of brain metastasis as an isolated first site of relapse was 45% in the control group and 19% in the treatment group (P < 10(-6)). The total 2-year rate of brain metastasis was 67% and 40%, respectively (relative risk = 0.35; P < 10(-13)). The 2-year overall survival rate was 21.5% in the control group and 29% in the treatment group (relative risk = 0.83; P = .14). There were no significant differences between the two groups in terms of neuropsychological function or abnormalities indicated by computed tomography brain scans. CONCLUSIONS: Prophylactic cranial irradiation given to patients with small-cell lung cancer in complete remission decreases the risk of brain metastasis threefold without a significant increase in complications. A possible beneficial effect on overall survival should be tested with a higher statistical power. IMPLICATIONS: The results of the trial favor, at present, the indication of prophylactic cranial irradiation for patients who are in complete remission. A longer follow-up and confirmatory trials are needed to fully assess late-occurring toxic effects. The possible effect on overall survival needs to be evaluated with a larger number of patients in complete remission, and a meta-analysis of similar trials is recommended.

Aged↗
PubMed1994

Alternating radiotherapy and chemotherapy in limited small cell lung cancer: the IGR protocols. French FNCLCC Lung Cancer Study Group.

Two-hundred two patients with limited small cell lung cancer were tested by four consecutive alternating radiotherapy and chemotherapy protocols. The alternating schedule consisted of six cycles of chemotherapy (doxorubicin, etoposide, and cyclophosphamide, plus methotrexate in the first protocol; cisplatin replaced methotrexate in the other three protocols) and three courses of thoracic radiotherapy at a total dose of 45, 55, 65 and 61 Gy in the four consecutive protocols, respectively. A 1-week rest followed each chemotherapy cycle and each course of radiotherapy. Seventy-six percent of patients were in complete remission at the end of the induction treatment. Overall results showed a 2-year cumulative incidence rate of failure of 75%. The first cause of failure was local recurrence only, 33%; distant only, 25%; distant and local simultaneously, 9%; and intercurrent death, 8%. Overall survival rate at 5 years was 16%. No significant differences were observed between the four treatment groups. Alternating radio-chemotherapy approaches are feasible and currently included in Phase III trials.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1994

Randomized study of vinorelbine and cisplatin versus vindesine and cisplatin versus vinorelbine alone in advanced non-small-cell lung cancer: results of a European multicenter trial including 612 patients.

PURPOSE: We designed a prospective randomized trial to compare vinorelbine and cisplatin (NVB-P) with vindesine and cisplatin (VDS-P) and to evaluate whether the best of these regimens affords a survival benefit compared with vinorelbine alone (NVB), an outpatient regimen, in patients with non-small-cell lung cancer (NSCLC). PATIENTS AND METHODS: Forty-five centers included 612 patients in this study: 206 on NVB-P, 200 on VDS-P, and 206 on NVB. Vinorelbine was administered at a dose of 30 mg/m2 weekly, cisplatin at 120 mg/m2 on days 1 and 29 and then every 6 weeks, and vindesine at 3 mg/m2 weekly for 6 weeks and then every other week. Treatment was continued until progression or toxicity. Four percent of the patients entered were ineligible and 59% had metastatic disease. RESULTS: An objective response rate was observed in 30% of patients in the NVB-P arm versus 19% in the VDS-P arm (P = .02) and 14% in the NVB arm (P < .001). The median duration of survival was 40 weeks in the NVB-P arm, compared with 32 weeks in the VDS-P arm and 31 weeks in the NVB arm. Comparison of survival among the three groups demonstrated an advantage for NVB-P compared with VDS-P (P = .04) and NVB (P = .01). Neutropenia was significantly higher in the NVB-P group (P < .001), and neurotoxicity was more frequent with VDS-P (P < .004). CONCLUSION: Since our results have demonstrated that NVB-P yields a longer survival duration and a higher response rate than VDS-P or NVB alone, with acceptable toxicity, this combination should be considered a relevant regimen in advanced NSCLC.

Aged↗
PubMed1994

A three-arm trial of vinorelbine (Navelbine) plus cisplatin, vindesine plus cisplatin, and single-agent vinorelbine in the treatment of non-small cell lung cancer: an expanded analysis.

Phase II studies have demonstrated that vinorelbine (Navelbine; Burroughs Wellcome Co, Research Triangle Park, NC; Pierre Fabre Médicament, Paris, France) alone or in combination with cisplatin has promising activity against non-small cell lung cancer (NSCLC). On the basis of these preliminary trials, a phase III study was designed to compare intravenous vinorelbine (30 mg/m2 weekly) plus cisplatin (120 mg/m2 on day 1 and day 29 and then every 6 weeks) with vindesine (3 mg/m2 weekly for 6 weeks and then every 2 weeks) plus cisplatin, and to evaluate whether the best of these regimens afforded a survival benefit compared with intravenous vinorelbine alone, an outpatient regimen. This report presents an expanded analysis of data from this previously published study. Six hundred twelve patients were enrolled in this trial: 206 in the vinorelbine plus cisplatin arm, 200 in the vindesine plus cisplatin group, and 206 in the single-agent vinorelbine arm. The vinorelbine plus cisplatin regimen was superior to the other two arms of the study in objective response rate (30% v 19% for vindesine plus cisplatin [P = .02] and 14% for vinorelbine alone [P = .001]), median survival duration (40 weeks v 32 weeks for vindesine plus cisplatin and 31 weeks for vinorelbine alone), and 1-year survival rate (35% v 27% for vindesine plus cisplatin and 30% for vinorelbine alone). An adjusted log-rank test provided a significant advantage for vinorelbine plus cisplatin when compared with vindesine plus cisplatin (P = .04) and with vinorelbine alone (P = .02). The major difference in survival between the two cisplatin-containing regimens occurred in patients with metastatic (stage IV) NSCLC. The incidence of granulocytopenia was significantly higher in the vinorelbine plus cisplatin arm compared with the other two treatment groups, but neurotoxicity was significantly more frequent in the vindesine plus cisplatin group. The results of this study indicate that the combination of vinorelbine plus cisplatin is a viable treatment option for patients with NSCLC and may provide advantages compared with other commonly used regimens.

Aged↗
PubMed1993

Initial chemotherapeutic doses and survival in patients with limited small-cell lung cancer.

BACKGROUND: Moderate increases in the initial doses of certain chemotherapeutic drugs, such as cisplatin and cyclophosphamide, may prolong overall survival in patients with limited small-cell lung cancer. METHODS: We conducted a prospective study of 105 patients with limited small-cell lung cancer. The patients were randomly assigned to receive higher or lower initial doses of cisplatin (100 or 80 mg per square meter of body-surface area) and cyclophosphamide (300 or 225 mg per square meter daily for four days); all patients received the same doses of doxorubicin and etoposide. The first course of chemotherapy was followed by five additional courses and by three courses of radiotherapy. All patients received the lower doses of cisplatin and cyclophosphamide and the same doses of doxorubicin and etoposide from the second through the sixth cycle of chemotherapy. RESULTS: The median follow-up was 33 months. The two-year survival rate for the 55 patients who received the higher doses of chemotherapy was 43 percent, as compared with 26 percent for the 50 patients who received the lower doses (P = 0.02). The rates of complete response at six months were 67 percent in the higher-dose group and 54 percent in the lower-dose group (P = 0.16). Disease-free survival at two years was 28 percent in the higher-dose group, as compared with 8 percent in the lower-dose group (P = 0.02). Side effects from treatment were not increased in the higher-dose group. CONCLUSIONS: Higher initial doses of cyclophosphamide and cisplatin improve disease-free and overall survival in patients with limited small-cell lung cancer.

Aged↗
PubMed1990

Alternating radiotherapy and chemotherapy in 173 consecutive patients with limited small cell lung carcinoma. GROP and the French Cancer Center's Lung Group.

One-hundred seventy-three patients with limited small cell lung cancer were included in three consecutive protocols alternating radiotherapy and chemotherapy. The alternating schedule consisted of six courses of chemotherapy (doxorubicin, VP16213, cyclophosphamide, and methotrexate in the first protocol; methotrexate being replaced by cisplatinum in the other two protocols) and three series of thoracic radiotherapy delivering a total dose of 45, 55, and 65 Gy in each consecutive protocol. Radiotherapy was started after the second course of chemotherapy. A 1-week gap was respected between each course of chemotherapy and each series of radiotherapy. Seventy percent of patients were in complete remission at the end of the induction treatment. The actuarial 5-year local control was 60% and the 5-year overall survival was 18%. Sixty percent of patients developed distant metastases. The death rate unrelated to cancer was 10%. These results show that alternating radiotherapy and chemotherapy schedules are reproducible, and provide a consistent long-term local control and a long-term survival rate exceeding 15% in limited disease.

Adult↗
PubMed1989

[Perspectives on chemotherapy of cancer of the bronchi].

Chemotherapy of epidermoid bronchial cancer maintains, despite numerous therapeutic trails, a minimal efficacy and is shown to have no important effect on the duration of survival. Conversely, the immediate results obtained by chemotherapy for small cell carcinoma are remarkable particularly for the localised forms; there are numerous active drugs which can be usefully combined with radiotherapy to increase the level of complete remission and to attempt to influence the eventual outcome which remains unfavourable. However, this chemotherapy should benefit from the multiple research programmes which are currently underway to reinforce the effects of chemotherapy (new combinations of effective cytotoxic drugs, and the potential for changing biological responses) and to improve the techniques of application (for example, continuous infusions and chronomodulation). The intensification of chemotherapy (with or without the use of marrow transplants) seems to constitute, by the reduction of tumour mass that is induced, a factor determining the improvement in long-term results but is still limited only to small cell carcinomas.

Antineoplastic Agents↗
PubMed1989

[Diagnosis of bilateral secondary tumors of the kidney. Contribution of cytology. Apropos of 2 cases].

The authors report bilateral secondary tumors of the kidney in two patients: one previously treated for an epidermoid tumor, the other for an anaplastic bronchial tumor. In both patients, clinical and radiological features were those of a malignant process. Scan-guided percutaneous fine needle aspiration provided the material necessary to make a definitive cytological diagnosis; it was thus possible to assess the malignancy and recognize the histological type of lesions.

Adult↗
PubMed1986

[Spontaneous regression of pulmonary images interpreted as metastases of kidney cancer. Apropos of 2 cases].

The authors report two cases of spontaneous regression of pulmonary metastases from hypernephroma; this is an exceptional event that occurs in 0.8% of metastasized renal carcinomas; spontaneous regression in all cancers as a group occurs in 0.0014% of cases. The theories postulated up till now to explain this phenomenon are unconvincing. The authors suggest the possibility of tumorous emboli: this event, that occurs mainly in those carcinomas with a propensity for extension to veins, such as renal carcinoma, choriocarcinoma, hepatoma and liver metastases, does not necessarily give rise to a metastasis. The evidence that leads to advocate nephrectomy in metastasized renal carcinoma are recalled and discussed.

Carcinoma, Renal Cell↗
PubMed1980

[Results of a sequential polychemotherapy (adriamycin, vincristine, cyclophosphamide, methotrexate) in small-cell and undifferentiated bronchial cancer].

40 patients suffering from inoperable bronchial cancer (25 anaplastic cancers, 15 undifferentiated cancers) were treated by a sequential association (Adriamycinee, Vincristine, Cyclophosphamide, Méthotrexate), repeated every 5 weeks. 28 patients already had metastatic cancer. A partial objective response (regression greater than 50%) was observed in 7 undifferentiated cancers and 14 anaplastic cancers. The treatment was interrupted 3 times for digestive and/or hematological toxicity; however, no deaths due to toxicity were reported. The mean survival is 8 months and 5 patients live for more than 18 months. The immediate effectiveness and mean survival place this protocol among polychemotherapies presently considered for this type of cancer. The number of evolutive recoveries observed during the maintenance stage settles the problem of the use of an efficient, slightly toxic and durable chemotherapy.

Adult↗