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The results of combination chemotherapy with etoposide, ifosfamide and cisplatin in patients with lung cancer (A preliminary report)
142
Abstracts/Lung
Cancer
disease, WC reviewed onr previous cases with pathologic Nl disease. We mtmqccUvcly investigated 78 patients with pathologic Nl disease who had undergone a complete resection with mediastinal lymph node dissection during the period from April 1972 to December 1990. The cumulative postoperative survival at 5 years was 49.2%. No significant ditfesence in the .wrvival was found according to the following variablea: sx, primary site, pathologic T factor, histologic type, type of resection, pformance ofadjwant therapy. The lcbar lymph nodes (Nos. 12 and 13) were only involved in 30 patients (38.5%). whereas the hilar nodes (Nos. 10 and 11) were involved in 48 patients (61.5%). The survival associated with lobar Nl disease was significantly better than that of hihr Nl disease (64.5Y~versus 39.74 at 5 years; p = 0.014). In lcbar Nl disease, the brain was the most frequent site of distant metastasis, wlweas the hmgs were the most frequent site in hilar Nl disease. It WM aggmtcd that pthologic Nl dirzase is a mixed group of potentially early stage disease and advanced stage disease with regard to the pouopedveprognosis.
Surgery for Stage IIIa-N2 non-small cell lung cancer Mountain CF. Box 109,1515 Holcombe Boulevcud, Houston, ZX 77030. Cancer 1994;73:2589-98. Background. The presence of ipsilateral mediastinal lymph node metastasis (N2 disease) in patients with non-small cell lung cancer presents a formidable challenge to the physician responsible for selecting therapy. The benefit of a surgical approach is controversial; however, it generally is agreed that only complete resection of all known tumor can provide a favorable outcome. This requires selecting patients for whom complete resection is a reasonable surgical objective. Methods. Retrospective review of a collected data base comprising records for 2883 patients who underwent definitive surgical treatment was accomplished to emphasize the prognostic implications of regional lymph node metastasis. Patients making up the N2 subset (n = 307) were the focus of the investigation. and providing insight to the puzzle of appropriate patient selection was a major goal. Results. Five-year cumuiative survival rates for patients with NO, Nl, ami N2 disease were, respectively, 62% 43% and 3 1%. Three factors significantly intluenced the outcome: a complete lymph node dissection, the extent of media&al lymph node involvement, and apparent complete resection of all tumor. Important survival determinants were the number of nodes involved, the level of involvement (single or multiple levels), and a Tl primary tumor status. Criteria for unresectability and recommendations for patient selection were developed from (1) the end results of the study and (2) the contributions of imaging and invasive techniques to clinical staging and to the histologic verification of nodai disease.
Chemotherapy The rearIts ofannbination chemotherapy with etoposide, ifosfamide and cisplatia in patients with lung cancer (A pvelimiaary report) Berk AO, Gzet A, Arpaci F. l’ip Onkoloji Bilim Dali, Gulhane Askeri l!pAkademisi, Et& Ankara. Bull Guihanehlil Med Acad 1994.36: ll4. From February 1992 through November 1993.40 lung cancer patients, both small cell (SCLC) and non-small (NSCLC) types, were enrolled in a clinical triai with VIP (etoposide, ifosfamide, cisplatin) regimen at GATA Medicai Oncology Department. of 40 patients enrolled, 16 patients (10 SCLC, 6 NSCLC) were iidly evahrable for response and survival. VIP regimen is given to metastanc and progressive despite radiotherapy, surgery and chemotherapy NSCLC patients. of 10 patients with SCLC. 7 cases were extensive and 3 cases were limited disease.
I2 (1995)
113-160
Doses of therapy were: etoposide 100 mg/m*/day on days 1 to 3, ifosfamide 1.5 g/m*/day on days I to 3, and cisplatin 20 mg/mVday on days 1 to 3. This regimen was repeated every 28 days for six cycles. In patients with SCLC, six patients (6033) had a complete remission and two patients (20%) had a partial remission (overall response rate 80%)/ with a median survival of 10.32 months. In patients with NSCLC, the overall rcsponsc rate was 50% and all were partial. Median survival in patients with NSCLC was 10.55 months. Grade III leukopenia and thrombccytopenia occurmd in 3 patient. The preliminary remits of the treatment showed the VIP regimen can be administered successfully in patients with SCLC and NSCLC. Incidence of neutropenic fever in patients treated with standarddose combination chemotherapy for smallceU luag cancer and the cost impact of treatment with granulocyte colony-stimulating factor Nichols CR, Fox EP, Roth BJ, Williams SD, Lc&rer PJ, Einhom LH. Division of Hematology/Oncology, Department of Medicine, 5’50 N University Blvd. Indianapolis, IN 46202-5265. J Clin Oncol 1994;12: 1245-50 Purpose: We sought to determine the incidence of neutropenic fever associated with the use of &andarddcse combination chemothempy for small- cell lung cancer (SCLC) and to use these data as a template toanal~thecostsandbenefitsoftberoutineusedgranulocyte colonystimulating factor (G-CSF). Patients and Method% We retrospectively reviewed records of 137 consecutive, unseiected patients with SCLC treated with combination chemotherapy from January 1987 to March 1992. Admission criteria for neutropenic fever were temperature 38.5”C and an absolute neutrophil count < 5OO/pL. Neutropenic fevers were managed with a 25% dose reduction of the myelosuppressive drugs in subsequent cycles. Charge estimates for hospitalization ($1,244 per day) and G-CSF use ($2,027 per course) were estimatedby reviewing charges to patients at Indiana University hospitalized for neutropenic fever or treated with outpatient G-CSF. We imposed assumptions from the Neupogen (filgrastim; Amgen Inc. Thousand Oaks, CA) licensing trial regarding the effectiveness of G-CSF and the Indiana University charge estimates on three models of GCSF use: (1) preemptive -with ail courses of chemotherapy, (2) reactive -with all cycles of chemotherapy following a neutropenic fever, and (3) dose reduction only (no G-CSF) - to derive charge estimates for G-CSF use. Results: Records of 137 patients with SCLC were identified and reviewed The incidence of neutropenic fever was 12% in the first cycle of chemotherapy, and 18% overall, compared with the placebo- and G-CSF-treated arms of the Neupogen licensing trial, in which the incidence of neutropenic fever was 77% and 40%, respectively. Other therapeutic outcomes, such as neutropenic septic deaths, response rates, and survival, were comparable. We derived the following charge estimates for the three models of GCSF: (1) preemptive - total charges = $1,287,481; (2) reactive - total charges = $276,154; and (3) dose reduction only - total charges = $192,820. Conclusion: The incidence of neutropenic fever with standarddose chemotherapy for SCLC was 18%. Routine use of G-CSF in SCLC patients treated with standarddose chemotherapy appears to be expensive and is not &ated with an obvious therapeutiche~fit or cost savings. We suggest that caretid analysis of the incidence of infectious complications, rather than grandoeyte nadir and duration, be performed, and that clinical guidelines for the use of these effective, but expensive, products be developed. Jfosfamide, carboplatin, and etoposide pfus granulacyte-macrophage qolony- stimulating factor: A phase I study with apparent activity in non-small-cell lung cancer Krigel RL, Palackdharry CS, Padavic K, Haas N, Kilpatrick D, Langer C et al. Deporhnent of Medicine, Medical College of Ohio. PO BOX 10008. Toledo, OH 43699-0008. J Clin Gncol 1994;12:1251-8.
Abstracts/Lung
Cancer
disease, WC reviewed onr previous cases with pathologic Nl disease. We mtmqccUvcly investigated 78 patients with pathologic Nl disease who had undergone a complete resection with mediastinal lymph node dissection during the period from April 1972 to December 1990. The cumulative postoperative survival at 5 years was 49.2%. No significant ditfesence in the .wrvival was found according to the following variablea: sx, primary site, pathologic T factor, histologic type, type of resection, pformance ofadjwant therapy. The lcbar lymph nodes (Nos. 12 and 13) were only involved in 30 patients (38.5%). whereas the hilar nodes (Nos. 10 and 11) were involved in 48 patients (61.5%). The survival associated with lobar Nl disease was significantly better than that of hihr Nl disease (64.5Y~versus 39.74 at 5 years; p = 0.014). In lcbar Nl disease, the brain was the most frequent site of distant metastasis, wlweas the hmgs were the most frequent site in hilar Nl disease. It WM aggmtcd that pthologic Nl dirzase is a mixed group of potentially early stage disease and advanced stage disease with regard to the pouopedveprognosis.
Surgery for Stage IIIa-N2 non-small cell lung cancer Mountain CF. Box 109,1515 Holcombe Boulevcud, Houston, ZX 77030. Cancer 1994;73:2589-98. Background. The presence of ipsilateral mediastinal lymph node metastasis (N2 disease) in patients with non-small cell lung cancer presents a formidable challenge to the physician responsible for selecting therapy. The benefit of a surgical approach is controversial; however, it generally is agreed that only complete resection of all known tumor can provide a favorable outcome. This requires selecting patients for whom complete resection is a reasonable surgical objective. Methods. Retrospective review of a collected data base comprising records for 2883 patients who underwent definitive surgical treatment was accomplished to emphasize the prognostic implications of regional lymph node metastasis. Patients making up the N2 subset (n = 307) were the focus of the investigation. and providing insight to the puzzle of appropriate patient selection was a major goal. Results. Five-year cumuiative survival rates for patients with NO, Nl, ami N2 disease were, respectively, 62% 43% and 3 1%. Three factors significantly intluenced the outcome: a complete lymph node dissection, the extent of media&al lymph node involvement, and apparent complete resection of all tumor. Important survival determinants were the number of nodes involved, the level of involvement (single or multiple levels), and a Tl primary tumor status. Criteria for unresectability and recommendations for patient selection were developed from (1) the end results of the study and (2) the contributions of imaging and invasive techniques to clinical staging and to the histologic verification of nodai disease.
Chemotherapy The rearIts ofannbination chemotherapy with etoposide, ifosfamide and cisplatia in patients with lung cancer (A pvelimiaary report) Berk AO, Gzet A, Arpaci F. l’ip Onkoloji Bilim Dali, Gulhane Askeri l!pAkademisi, Et& Ankara. Bull Guihanehlil Med Acad 1994.36: ll4. From February 1992 through November 1993.40 lung cancer patients, both small cell (SCLC) and non-small (NSCLC) types, were enrolled in a clinical triai with VIP (etoposide, ifosfamide, cisplatin) regimen at GATA Medicai Oncology Department. of 40 patients enrolled, 16 patients (10 SCLC, 6 NSCLC) were iidly evahrable for response and survival. VIP regimen is given to metastanc and progressive despite radiotherapy, surgery and chemotherapy NSCLC patients. of 10 patients with SCLC. 7 cases were extensive and 3 cases were limited disease.
I2 (1995)
113-160
Doses of therapy were: etoposide 100 mg/m*/day on days 1 to 3, ifosfamide 1.5 g/m*/day on days I to 3, and cisplatin 20 mg/mVday on days 1 to 3. This regimen was repeated every 28 days for six cycles. In patients with SCLC, six patients (6033) had a complete remission and two patients (20%) had a partial remission (overall response rate 80%)/ with a median survival of 10.32 months. In patients with NSCLC, the overall rcsponsc rate was 50% and all were partial. Median survival in patients with NSCLC was 10.55 months. Grade III leukopenia and thrombccytopenia occurmd in 3 patient. The preliminary remits of the treatment showed the VIP regimen can be administered successfully in patients with SCLC and NSCLC. Incidence of neutropenic fever in patients treated with standarddose combination chemotherapy for smallceU luag cancer and the cost impact of treatment with granulocyte colony-stimulating factor Nichols CR, Fox EP, Roth BJ, Williams SD, Lc&rer PJ, Einhom LH. Division of Hematology/Oncology, Department of Medicine, 5’50 N University Blvd. Indianapolis, IN 46202-5265. J Clin Oncol 1994;12: 1245-50 Purpose: We sought to determine the incidence of neutropenic fever associated with the use of &andarddcse combination chemothempy for small- cell lung cancer (SCLC) and to use these data as a template toanal~thecostsandbenefitsoftberoutineusedgranulocyte colonystimulating factor (G-CSF). Patients and Method% We retrospectively reviewed records of 137 consecutive, unseiected patients with SCLC treated with combination chemotherapy from January 1987 to March 1992. Admission criteria for neutropenic fever were temperature 38.5”C and an absolute neutrophil count < 5OO/pL. Neutropenic fevers were managed with a 25% dose reduction of the myelosuppressive drugs in subsequent cycles. Charge estimates for hospitalization ($1,244 per day) and G-CSF use ($2,027 per course) were estimatedby reviewing charges to patients at Indiana University hospitalized for neutropenic fever or treated with outpatient G-CSF. We imposed assumptions from the Neupogen (filgrastim; Amgen Inc. Thousand Oaks, CA) licensing trial regarding the effectiveness of G-CSF and the Indiana University charge estimates on three models of GCSF use: (1) preemptive -with ail courses of chemotherapy, (2) reactive -with all cycles of chemotherapy following a neutropenic fever, and (3) dose reduction only (no G-CSF) - to derive charge estimates for G-CSF use. Results: Records of 137 patients with SCLC were identified and reviewed The incidence of neutropenic fever was 12% in the first cycle of chemotherapy, and 18% overall, compared with the placebo- and G-CSF-treated arms of the Neupogen licensing trial, in which the incidence of neutropenic fever was 77% and 40%, respectively. Other therapeutic outcomes, such as neutropenic septic deaths, response rates, and survival, were comparable. We derived the following charge estimates for the three models of GCSF: (1) preemptive - total charges = $1,287,481; (2) reactive - total charges = $276,154; and (3) dose reduction only - total charges = $192,820. Conclusion: The incidence of neutropenic fever with standarddose chemotherapy for SCLC was 18%. Routine use of G-CSF in SCLC patients treated with standarddose chemotherapy appears to be expensive and is not &ated with an obvious therapeutiche~fit or cost savings. We suggest that caretid analysis of the incidence of infectious complications, rather than grandoeyte nadir and duration, be performed, and that clinical guidelines for the use of these effective, but expensive, products be developed. Jfosfamide, carboplatin, and etoposide pfus granulacyte-macrophage qolony- stimulating factor: A phase I study with apparent activity in non-small-cell lung cancer Krigel RL, Palackdharry CS, Padavic K, Haas N, Kilpatrick D, Langer C et al. Deporhnent of Medicine, Medical College of Ohio. PO BOX 10008. Toledo, OH 43699-0008. J Clin Gncol 1994;12:1251-8.