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The clinical effect of medroxyprogesterone (MPA) in elderly patients with lung cancer
Thrrty-one patients with histologically prove” small cell lung cancer were treated with cyclophosphamide 1 g m *andecoposide (VPl6-213) 125 mg m ‘both intravenously on day 1 followed by ecoposide 250 mg mz orally on days 2-3 for a maximum of six courses at 3 weekly mtcrvals. Fourteen patic”& had limited and 17 patients had extensive disease. Twenty-five patients were evaluable for response. Objectwe response was observed in 18 patients (58%) with 6 (19%) complete and 12 (39%) partial responses. Medial survival of the entire group of patients was 30 weeks. There was significant survival benefit among the responders (P < 0.005) when compared with non-responders. One patient (3.3%) developed grade 4 while 60% of patients developed grade 1-2 haematological toxicity. Other side effects were relatively mild. WC conclude that combination cyclophosphamlde and etoposide was active in small cell lung cancer and relatively well tolerated.
Combination chemotherapy with mitomycin, vindesine, and cisplatin for non-small cell lung cancer. Association of antitumor activity with initial tumor burden and treatment center Joss RA, Burke K, Dalquen Pet al. Division of0ncology. Department CH-6004 Luzern. Cancer 1990:65:2426of Medicine. Kantonssp~ml, 34. From 1984 through 1986, 205 patients with non-small cell lung cancer were entered into a group-wade trial of the Swiss Group for ClmicalCancer Research (SAKK).Thistrialevaluated thecombination of mitomycin (8 mg/m’intravenously [IV] on day I), vindesine (3 mg/ m2 IV on days 1 and 8), and crsplatin (60 mg/m” IV on day 1) wth forced dmresis.repeacedevery4 weeks(MiViPregimen).Onehundredeightythree pauents were evaluahle. Six complete and 69 partial responses were documented for an overall response rate of 4 1% (95 % confidence interval, 34% to 50%). In the multivariate analysis the strongest predictors for response were the partrcipating institution and the number of initially involved organ sites. The estimated median time to progression for patrents with a complete response, partial response, or stable disease was 155 days (estimated Inter-quartile range, 99 to 258 days). In the multivariate analysis the time to progression was significantly associated wh the number of mvolved organ sites (P = 0.041). The estimated median survival time for the 183 evaluable patients was 239 days (estimated interquartile range, 137 to436 days). In univariate and multivariate analyses the time to progression was significantly associated with Ihe number of involved organ sites (P = 0.041). The estimated me&an survival crme for the 183 evaluable patients was 239 days (estimated interquartile range, 137 to436days). In univariate and multivariate analyses performance smatus, number of involved organ FICCS,pretrcalment status with radiation therapy, and participating instltut~on wereall significantly associated with survival. The prmcipal toxlciucs were myelosuppression and nauca and vomtcmg with 16% of the patients refusing further trcatmem after a media” of four cycles of chemotherapy. In conclusion, the MiVrP regimen was a” active combination chemotherapy in patients with non-small cell lung cancer in a large ura1 performed by the SAKK. The prognosclc value of the participating insdtution and the number of organ sites involved by metaqtacic deposits in non-small cell lung cancer needs further investigation.
The clinical effect of medroxyprogesterone (MPA) in elderly patients with lung cancer Niiranen A, Kajanti M, Tammilchto L, Mattson K. Deparmwn~ of Pulmonary
Medicine
versiry Cenira/HosprmL
and Radiotheraoy Helsinki.
and Oncology,
Helsinki
Uni-
Am J Clin Oncol Cancer Clin Trials
1990:13:113-6. bghty-nine patients over 70 years old with untreated lung cancer, of various cell type and in various stages, were randomly awgned to chemotherapy (CT) alone or CT combined wrth medroxyprogesterone aceuxe (MPA). CT consIsted of cisplatin, 60 mg/m’ i.v., along with etoposide (W-16). 150 mg/m”i.v., on day 1. The VP-16 was increased to 200 mg/m”. orally, on day 3. The entire regimen was given every 4 weeks for a maximum of six cycles. MPA was administered in daily 500-mg doses, i.m., 5 days a week for 1 month, followed by 1000 mg i.m., once a week, for 5 months. Changes in body weight and appetite wcrc documented. After two cycles of CT, 64 patients were found to be
evaluable for response. Forty-five had non-small-cell lung cancer (NSCLC) and 19 had small-cell lung cancer (SCLC). Thirty-seven patients had received CT alone and 27 CT plus MPA. In NSCLC, the objectivercsponse coCTalonewas36% versus37% withCTplusMPA. In SCLC, the corresponding figures were 63% and 22%. The overall objective response rate was 60% in NSCLC and 48% in SCLC. Median survwal using CT alone was 10 months for NSCLC patients and 1 I months for SCLC patients. Usmg CT plus MPA, it was 10 months for NSCLC patlencs and 7 months for SCLC patients. In the control arm, lyear survival was426 for NSCLC pawnis and48% for SCLCpatients; m those who were given MPA, it was 48% for NSCLC patrents and 9% for SCLC palien&. Improved appetite and weight gain were reported more frequently by MPA patients, and they did not complam of CT’s usual side effects. The fact thal MPA had no sigmfrcant effect on CT response or survival in patients also treated with a combination of cisplatin and VP- 16, along with the small surwval advamage for the control group in SCLC patients, suggests chat combmmg MPA and CT may result in improved quality of life.
Ifosfamide with mesna uroprotection in the management of lung cancer Holoye PY, Glisson BS, Lee JS et al. Deparlment ofMedical Oncology, Box 80, M.D. Ilousion.
Anderson
‘TX 77030.
Cancer
Center,
1515
Holcombe
Boulevard,
Am I Clm Oncol Cancer Clin Trials 1990; 13: 148.
55. Fourteen patients with extensive disease small cell bronchogemc carcinoma (SCBC) received ifosfamide at 2,000 mg/m2/day for 5 consecutive days with simultaneous mesna and vmcrisline while 26 palien& withextensivediseasenon-small-cell bronchogeniccarcinoma (N-SCBC) received the same regimen without vmcrisune. Eight partial responses (57%) were observed with a 40-week median survival in the case of SCBC and four partial remissions (15%) with a 3 1-week median survival in N-SCBC. Granulocycopenia was the dose -linuting toxicity, whereas urotoxiclty was well controlled wth mesna. Neuropsychiatric Ioxrcicy consisted of anxrety. agitation, confusion, and hallucmacion. Neurobehavioral testing detected worsened performanceduring ifosfamide treatment. Ifosfamidc is one of the few active agents in N-SCBC.
A phase II study of ifosfamide, cisplatin, etoposide in patients with advanced non-small cell lung cancer: A preliminary report Shepherd FA, Goss PE, Latreille J et al. Deparrmenr of Medicine. TorontoHospiral,200ElizabethSrreer,Toronro,On~. MSG2C4. Semi” Oncol 1990;17:Suppl4:19-23. Twenty previously untreated patients wth histologically orcytologitally prove” non-small cell lung cancer (NSCLC) were treated with lfosfamide in combination with cisplatm and etoposide. Patients received lfosfamide 4 g/m’ wilh mesna uroprocection on day 1 and cisplatin 25 mgfm’ and etoposide 100 mg/m’ on days 1 through 3. Courses were repeated every 28 days. Premeditation ~5th prochlorperazine, dexamethasone, and high-dose metoclopramide was given to prevent nausea, and lorazepam was added on days 2 and 3 only. Seventeen male and three female patients (median age, 57 years) have been treated. Two patients had stage IIIb dweascas, and 18 had hematogenous metastascs. Eighteen pacienls are evaluable for response and toxicy, and it is too early co evaluate two patients. Early m the study, two patients dred of toxicity and have been classified as nonresponders. One patient achieved complete response (21 + weeks), and seven patients achieved partial response (median. 30+ weeks; range, 5 co 38+), for an overal response rate of 44.5%. The medran survival of the group has nor been reached, and 14 patients arc alive 5 LO38+ weeks from the start of treatment. The media” nadir granulocyce count was 0.275 x lop/L (range, 0 to 2.283 X Iv/L), and there were SIXepisodes (involvmg 5 patrents) of neuvopenia-associate fever, one of which resulted in death. The median nadir platelel count was 120 x 109/L (range, 13 to 385 x lop/L), but no paclcnt experienced bleeding or required platelet uansfus~ons. Five paleints reqmred RBC transfusions. Only erght patients had grade 2 gasuomtestinal loxicily, and one patient had microscopic hematuria: there wa$ no CNS conicrcy.
Combination chemotherapy with mitomycin, vindesine, and cisplatin for non-small cell lung cancer. Association of antitumor activity with initial tumor burden and treatment center Joss RA, Burke K, Dalquen Pet al. Division of0ncology. Department CH-6004 Luzern. Cancer 1990:65:2426of Medicine. Kantonssp~ml, 34. From 1984 through 1986, 205 patients with non-small cell lung cancer were entered into a group-wade trial of the Swiss Group for ClmicalCancer Research (SAKK).Thistrialevaluated thecombination of mitomycin (8 mg/m’intravenously [IV] on day I), vindesine (3 mg/ m2 IV on days 1 and 8), and crsplatin (60 mg/m” IV on day 1) wth forced dmresis.repeacedevery4 weeks(MiViPregimen).Onehundredeightythree pauents were evaluahle. Six complete and 69 partial responses were documented for an overall response rate of 4 1% (95 % confidence interval, 34% to 50%). In the multivariate analysis the strongest predictors for response were the partrcipating institution and the number of initially involved organ sites. The estimated median time to progression for patrents with a complete response, partial response, or stable disease was 155 days (estimated Inter-quartile range, 99 to 258 days). In the multivariate analysis the time to progression was significantly associated wh the number of mvolved organ sites (P = 0.041). The estimated median survival time for the 183 evaluable patients was 239 days (estimated interquartile range, 137 to436 days). In univariate and multivariate analyses the time to progression was significantly associated with Ihe number of involved organ sites (P = 0.041). The estimated me&an survival crme for the 183 evaluable patients was 239 days (estimated interquartile range, 137 to436days). In univariate and multivariate analyses performance smatus, number of involved organ FICCS,pretrcalment status with radiation therapy, and participating instltut~on wereall significantly associated with survival. The prmcipal toxlciucs were myelosuppression and nauca and vomtcmg with 16% of the patients refusing further trcatmem after a media” of four cycles of chemotherapy. In conclusion, the MiVrP regimen was a” active combination chemotherapy in patients with non-small cell lung cancer in a large ura1 performed by the SAKK. The prognosclc value of the participating insdtution and the number of organ sites involved by metaqtacic deposits in non-small cell lung cancer needs further investigation.
The clinical effect of medroxyprogesterone (MPA) in elderly patients with lung cancer Niiranen A, Kajanti M, Tammilchto L, Mattson K. Deparmwn~ of Pulmonary
Medicine
versiry Cenira/HosprmL
and Radiotheraoy Helsinki.
and Oncology,
Helsinki
Uni-
Am J Clin Oncol Cancer Clin Trials
1990:13:113-6. bghty-nine patients over 70 years old with untreated lung cancer, of various cell type and in various stages, were randomly awgned to chemotherapy (CT) alone or CT combined wrth medroxyprogesterone aceuxe (MPA). CT consIsted of cisplatin, 60 mg/m’ i.v., along with etoposide (W-16). 150 mg/m”i.v., on day 1. The VP-16 was increased to 200 mg/m”. orally, on day 3. The entire regimen was given every 4 weeks for a maximum of six cycles. MPA was administered in daily 500-mg doses, i.m., 5 days a week for 1 month, followed by 1000 mg i.m., once a week, for 5 months. Changes in body weight and appetite wcrc documented. After two cycles of CT, 64 patients were found to be
evaluable for response. Forty-five had non-small-cell lung cancer (NSCLC) and 19 had small-cell lung cancer (SCLC). Thirty-seven patients had received CT alone and 27 CT plus MPA. In NSCLC, the objectivercsponse coCTalonewas36% versus37% withCTplusMPA. In SCLC, the corresponding figures were 63% and 22%. The overall objective response rate was 60% in NSCLC and 48% in SCLC. Median survwal using CT alone was 10 months for NSCLC patients and 1 I months for SCLC patients. Usmg CT plus MPA, it was 10 months for NSCLC patlencs and 7 months for SCLC patients. In the control arm, lyear survival was426 for NSCLC pawnis and48% for SCLCpatients; m those who were given MPA, it was 48% for NSCLC patrents and 9% for SCLC palien&. Improved appetite and weight gain were reported more frequently by MPA patients, and they did not complam of CT’s usual side effects. The fact thal MPA had no sigmfrcant effect on CT response or survival in patients also treated with a combination of cisplatin and VP- 16, along with the small surwval advamage for the control group in SCLC patients, suggests chat combmmg MPA and CT may result in improved quality of life.
Ifosfamide with mesna uroprotection in the management of lung cancer Holoye PY, Glisson BS, Lee JS et al. Deparlment ofMedical Oncology, Box 80, M.D. Ilousion.
Anderson
‘TX 77030.
Cancer
Center,
1515
Holcombe
Boulevard,
Am I Clm Oncol Cancer Clin Trials 1990; 13: 148.
55. Fourteen patients with extensive disease small cell bronchogemc carcinoma (SCBC) received ifosfamide at 2,000 mg/m2/day for 5 consecutive days with simultaneous mesna and vmcrisline while 26 palien& withextensivediseasenon-small-cell bronchogeniccarcinoma (N-SCBC) received the same regimen without vmcrisune. Eight partial responses (57%) were observed with a 40-week median survival in the case of SCBC and four partial remissions (15%) with a 3 1-week median survival in N-SCBC. Granulocycopenia was the dose -linuting toxicity, whereas urotoxiclty was well controlled wth mesna. Neuropsychiatric Ioxrcicy consisted of anxrety. agitation, confusion, and hallucmacion. Neurobehavioral testing detected worsened performanceduring ifosfamide treatment. Ifosfamidc is one of the few active agents in N-SCBC.
A phase II study of ifosfamide, cisplatin, etoposide in patients with advanced non-small cell lung cancer: A preliminary report Shepherd FA, Goss PE, Latreille J et al. Deparrmenr of Medicine. TorontoHospiral,200ElizabethSrreer,Toronro,On~. MSG2C4. Semi” Oncol 1990;17:Suppl4:19-23. Twenty previously untreated patients wth histologically orcytologitally prove” non-small cell lung cancer (NSCLC) were treated with lfosfamide in combination with cisplatm and etoposide. Patients received lfosfamide 4 g/m’ wilh mesna uroprocection on day 1 and cisplatin 25 mgfm’ and etoposide 100 mg/m’ on days 1 through 3. Courses were repeated every 28 days. Premeditation ~5th prochlorperazine, dexamethasone, and high-dose metoclopramide was given to prevent nausea, and lorazepam was added on days 2 and 3 only. Seventeen male and three female patients (median age, 57 years) have been treated. Two patients had stage IIIb dweascas, and 18 had hematogenous metastascs. Eighteen pacienls are evaluable for response and toxicy, and it is too early co evaluate two patients. Early m the study, two patients dred of toxicity and have been classified as nonresponders. One patient achieved complete response (21 + weeks), and seven patients achieved partial response (median. 30+ weeks; range, 5 co 38+), for an overal response rate of 44.5%. The medran survival of the group has nor been reached, and 14 patients arc alive 5 LO38+ weeks from the start of treatment. The media” nadir granulocyce count was 0.275 x lop/L (range, 0 to 2.283 X Iv/L), and there were SIXepisodes (involvmg 5 patrents) of neuvopenia-associate fever, one of which resulted in death. The median nadir platelel count was 120 x 109/L (range, 13 to 385 x lop/L), but no paclcnt experienced bleeding or required platelet uansfus~ons. Five paleints reqmred RBC transfusions. Only erght patients had grade 2 gasuomtestinal loxicily, and one patient had microscopic hematuria: there wa$ no CNS conicrcy.