VINCRISTINE IN THE TREATMENT OF ACUTE LEUKEMIA IN CHILDREN

PEDIATRICS ◽  
1966 ◽  
Vol 38 (1) ◽  
pp. 82-91
Author(s):  
Ruth M. Heyn ◽  
E. C. Beatty ◽  
D. Hammond ◽  
J. Louis ◽  
M. Pierce ◽  
...  
Keyword(s):  
Complete Remission ◽  
Maintenance Therapy ◽  
Acute Leukemia ◽  
Median Duration ◽  
Drug Toxicity ◽  
Gastrointestinal Symptoms ◽  
Duration Of Disease ◽  
Common Problems ◽  
Leukemia In Children ◽  
Onset Of Remission

Vcr induced complete marrow remission in 43% of children with all types of acute leukemia who were refractory to other antileukemic therapy. The median duration of disease before Vcr treatment was 13.5 months. The marrow response in those patients achieving an A marrow was rapid with a marked clearing of the blasts by 14 days and a complete remission by 28 days. The median duration of complete remission with and without maintenance therapy was 63.5 and 59 days, respectively. Drug toxicity occurred in about half the patients, limiting the total dose of drug that could be given. Leukopenia, alopecia, gastrointestinal symptoms, and neurotoxicity were the most common problems seen. These were reversible on withdrawal of the drug. Remissions were not improved by increasing the dose of Vcr to 0.1 mg/kg for two or more doses after 4 doses of 0.075 mg/kg. The reduction in dose necessitated by drug toxicity was not detrimental to a good response since the children attaining complete remissions experienced the greatest number of alterations in dose prior to the onset of remission.

scholarly journals Chemotherapy for acute myelogenous leukemia in children and adults: VAPA update

Blood ◽  
1983 ◽  
Vol 62 (2) ◽  
pp. 315-319 ◽  
Author(s):  
HJ Weinstein ◽  
RJ Mayer ◽  
DS Rosenthal ◽  
FS Coral ◽  
BM Camitta ◽  
...  
Keyword(s):  
Complete Remission ◽  
Maintenance Therapy ◽  
Induction Chemotherapy ◽  
Acute Myelogenous Leukemia ◽  
Myelogenous Leukemia ◽  
Kaplan Meier ◽  
High Incidence ◽  
Acute Myelogenous ◽  
Leukemia In Children

Abstract We designed a protocol (VAPA) that featured 14 mo of intensive postremission induction chemotherapy in an effort to improve remission durations for patients with acute myelogenous leukemia (AML). One hundred and seven patients under 50 yr of age were entered into this study. The rate of complete remission is 70%. A Kaplan-Meier analysis of patients entering remission predicts that 56% +/- 7% (+/-SE) of patients less than 18 yr and 45% +/- 9% of patients aged 18–50 yr will remain in remission at 3 yr (median follow-up is 43 mo). Patients with the monocytic subtype had a statistically significant shorter duration of remission (2-sided p less than 0.05). There was a high incidence of primary CNS relapse in children. Thirty-one of 41 patients who completed the regimen remain in remission without maintenance therapy. We conclude that the VAPA protocol continues to offer a promising approach to treatment of AML.

OPTIMOX2, a large randomized phase II study of maintenance therapy or chemotherapy-free intervals (CFI) after FOLFOX in patients with metastatic colorectal cancer (MRC). A GERCOR study

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 3504-3504 ◽  
Author(s):  
F. Maindrault-Goebel ◽  
G. Lledo ◽  
B. Chibaudel ◽  
L. Mineur ◽  
T. Andre ◽  
...  
Keyword(s):  
Maintenance Therapy ◽  
Phase Ii ◽  
Median Duration ◽  
Phase Ii Study ◽  
Phase Iii ◽  
Randomized Phase Ii ◽  
Phase Iii Study ◽  
Large Phase ◽  
Duration Of Disease

3504 Background: The OPTIMOX1 study (JCO 2006) has shown that the strategy of 6 cycles of FOLFOX7 followed by maintenance therapy and FOLFOX reintroduction was as active and better tolerated than FOLFOX4 until progression. The aim of the OPTIMOX2 study was to evaluate a complete stop of chemotherapy after 6 bimonthly cycles of FOLFOX. Methods: Initially planned as a phase III study, OPTIMOX2 was downgraded to a large phase II study since the availability of bevacizumab. Patients (pts) were randomized between an OPTIMOX1 arm: 6 cycles of FOLFOX7 followed by LV5FU until progression and reintroduction of FOLFOX7, and the OPTIMOX2 arm: 6 cycles of FOLFOX7, complete stop of chemotherapy and reintroduction of FOLFOX7 before the tumor progression reached the baseline measures. Results: 187/200 planned pts were included between Feb 2004 and Nov 2005. Response rates were (OPTIMOX1 arm/OPTIMOX2 arm): CR 2%/2%, PR 54%/51%, stable 24%/33%, progression 11%/7%, non assessable 9%/7%. Median PFS were (OPTIMOX1 arm/OPTIMOX2 arm) 36/28 weeks (p=.01), PFS in responders 41/30 weeks (p=.001), PFS in stable patients 34/26 weeks (p=.23). Median duration of disease control (DDC), addition of PFS of first FOLFOX7 administration plus PFS of FOLFOX reintroduction if no progression at first evaluation, was 41 weeks in the OPTIMOX1 arm and 36 in the OPTIMOX2 arm, p=.17. Median duration of chemotherapy-free interval in the OPTIMOX2 arm was 25 weeks (5.7 months). Conclusions: Maintenance LV5FU therapy prolongs PFS. The quality of life of almost 6 months CFI can balance a small advantage in DDC for maintenance therapy. Our next goal is to evaluate maintenance therapy with targeted agents alone. [Table: see text]

Final results of OPTIMOX2, a large randomized phase II study of maintenance therapy or chemotherapy-free intervals (CFI) after FOLFOX in patients with metastatic colorectal cancer (MRC): A GERCOR study

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 4013-4013 ◽  
Author(s):  
F. Maindrault-Goebel ◽  
G. Lledo ◽  
B. Chibaudel ◽  
L. Mineur ◽  
T. Andre ◽  
...  
Keyword(s):  
Prognostic Factors ◽  
Maintenance Therapy ◽  
Phase Ii ◽  
Median Duration ◽  
Median Overall Survival ◽  
Phase Ii Study ◽  
Free Interval ◽  
Randomized Phase Ii ◽  
Large Phase ◽  
Duration Of Disease

4013 Background: The OPTIMOX2 study was designed to evaluate a complete stop of chemotherapy after 6 bimonthly cycles of FOLFOX. Methods: OPTIMOX2 is a large phase II study performed before the availability of bevacizumab. Patients (pts) were randomized between an OPTIMOX1 arm: 6 cycles of FOLFOX7 followed by LV5FU2 until progression then reintroduction of FOLFOX7, and the OPTIMOX2 arm: 6 cycles of FOLFOX7, complete stop of chemotherapy and reintroduction of FOLFOX7 before the tumor progression reached the baseline measures. Results: 202 pts were included between Feb 2004 and Apr 2006. Response rates were (OPTIMOX1/OPTIMOX2): CR+PR 63%/61%. Median PFS were OPTIMOX1/OPTIMOX2) 8.3/6.7 months (p=.04). Median duration of disease control (DDC), addition of PFS of first FOLFOX7 administration plus PFS of FOLFOX reintroduction if no progression at first evaluation, was 10.8m in the OPTIMOX1 arm and 9.0m in the OPTIMOX2 arm, p=.32. Median duration of chemotherapy-free interval (CFI) in the OPTIMOX2 arm was 4.6 months. Patients with poor prognostic factors had a shorter CFI, p=.01. Median overall survival was 24.6m in the OPTIMOX1 arm and 18.9m in the OPTIMOX2 arm, p=.05. Median survivals (OPTIMOX1/OPTIMOX2) were not reached/28.7m in patients with good prognostic and 20.9/14.5m in patients with poor prognostic. Conclusions: Maintenance LV5FU therapy prolongs PFS and OS, especially in patients with poor prognosis. CFI can be recommended only in selected patients without adverse prognostic factors. Our next study, DREAM, is evaluating maintenance therapy with targeted agents alone. No significant financial relationships to disclose.

scholarly journals Evaluation of AMSA in previously treated patients with acute leukemia: results of therapy in 109 adults

Blood ◽  
1982 ◽  
Vol 60 (2) ◽  
pp. 484-490 ◽  
Author(s):  
SS Legha ◽  
MJ Keating ◽  
KB McCredie ◽  
GP Bodey ◽  
EJ Freireich
Keyword(s):  
Side Effects ◽  
Complete Remission ◽  
Acute Leukemia ◽  
Median Duration ◽  
Optimum Dose ◽  
Remission Induction ◽  
Anthracycline Antibiotics ◽  
Blastic Phase ◽  
Previously Treated Patients ◽  
Previously Treated

AMSA was evaluated in the treatment of 109 adults with previously treated acute leukemia. Of the 102 evaluable patients, 82 had AML, 17 ALL, and 3 CML in blastic phase. A number of different dose schedules of AMSA were explored, and we conclude that the optimum dose of AMSA for remission induction in acute leukemia is 120 mg/sq m/day for 5 days. Complete remissions were observed in 23 (28%) patients with AML and in 1 patient with ALL. Patients who achieved complete remission were maintained on AMSA using a dose of 30–40 mg/sq m/day for 5 days repeated at 4-wk intervals. The median duration of complete remission was 12 wk (3–59 wk), and the responders survived significantly longer than the failures (27 wk versus 8 wk, p = 0.002). The side effects associated with AMSA therapy included mild nausea and vomiting, stomatitis, diarrhea, phlebitis, alopecia, and myelosuppression-related infections. Our results indicate that AMSA is a useful new antileukemic agent for the treatment of relapsed acute leukemia and appears to have activity comparable to that of the currently available drugs, such as cytarabine and the anthracycline antibiotics.

scholarly journals Chemotherapy for acute myelogenous leukemia in children and adults: VAPA update

Blood ◽  
1983 ◽  
Vol 62 (2) ◽  
pp. 315-319 ◽  
Author(s):  
HJ Weinstein ◽  
RJ Mayer ◽  
DS Rosenthal ◽  
FS Coral ◽  
BM Camitta ◽  
...  
Keyword(s):  
Complete Remission ◽  
Maintenance Therapy ◽  
Induction Chemotherapy ◽  
Acute Myelogenous Leukemia ◽  
Myelogenous Leukemia ◽  
Kaplan Meier ◽  
High Incidence ◽  
Acute Myelogenous ◽  
Leukemia In Children

We designed a protocol (VAPA) that featured 14 mo of intensive postremission induction chemotherapy in an effort to improve remission durations for patients with acute myelogenous leukemia (AML). One hundred and seven patients under 50 yr of age were entered into this study. The rate of complete remission is 70%. A Kaplan-Meier analysis of patients entering remission predicts that 56% +/- 7% (+/-SE) of patients less than 18 yr and 45% +/- 9% of patients aged 18–50 yr will remain in remission at 3 yr (median follow-up is 43 mo). Patients with the monocytic subtype had a statistically significant shorter duration of remission (2-sided p less than 0.05). There was a high incidence of primary CNS relapse in children. Thirty-one of 41 patients who completed the regimen remain in remission without maintenance therapy. We conclude that the VAPA protocol continues to offer a promising approach to treatment of AML.

scholarly journals Evaluation of AMSA in previously treated patients with acute leukemia: results of therapy in 109 adults

Blood ◽  
1982 ◽  
Vol 60 (2) ◽  
pp. 484-490 ◽  
Author(s):  
SS Legha ◽  
MJ Keating ◽  
KB McCredie ◽  
GP Bodey ◽  
EJ Freireich
Keyword(s):  
Side Effects ◽  
Complete Remission ◽  
Acute Leukemia ◽  
Median Duration ◽  
Optimum Dose ◽  
Remission Induction ◽  
Anthracycline Antibiotics ◽  
Blastic Phase ◽  
Previously Treated Patients ◽  
Previously Treated

Abstract AMSA was evaluated in the treatment of 109 adults with previously treated acute leukemia. Of the 102 evaluable patients, 82 had AML, 17 ALL, and 3 CML in blastic phase. A number of different dose schedules of AMSA were explored, and we conclude that the optimum dose of AMSA for remission induction in acute leukemia is 120 mg/sq m/day for 5 days. Complete remissions were observed in 23 (28%) patients with AML and in 1 patient with ALL. Patients who achieved complete remission were maintained on AMSA using a dose of 30–40 mg/sq m/day for 5 days repeated at 4-wk intervals. The median duration of complete remission was 12 wk (3–59 wk), and the responders survived significantly longer than the failures (27 wk versus 8 wk, p = 0.002). The side effects associated with AMSA therapy included mild nausea and vomiting, stomatitis, diarrhea, phlebitis, alopecia, and myelosuppression-related infections. Our results indicate that AMSA is a useful new antileukemic agent for the treatment of relapsed acute leukemia and appears to have activity comparable to that of the currently available drugs, such as cytarabine and the anthracycline antibiotics.

scholarly journals The Effect of 6-Mercaptopurine on the Duration of Steroid-induced Remissions in Acute Leukemia: A Model for Evaluation of Other Potentially Useful Therapy

Blood ◽  
1963 ◽  
Vol 21 (6) ◽  
pp. 699-716 ◽  
Author(s):  
◽  
EMIL J FREIREICH ◽  
EDMUND GEHAN ◽  
EMIL FREI ◽  
LESLIE R. SCHROEDER ◽  
...  
Keyword(s):  
Overall Survival ◽  
Experimental Design ◽  
Maintenance Therapy ◽  
Acute Leukemia ◽  
Median Duration ◽  
Treatment Programs ◽  
New Agents ◽  
Maintenance Activity ◽  
Remission Maintenance

Abstract The effect of 6-MP therapy on the duration of remissions induced by adrenal corticosteroids has been studied as a model for testing of new agents. Ninetytwo patients under age 20 entered the study and were accepted for analysis. Sixty-two (67 per cent) had complete or partial remissions induced by corticosteroids. Patients in remission were randomly assigned to maintenance therapy with either 6-MP or placebo. The median duration of 6-MP-maintained complete remissions was 33 weeks and for placebo, 9 weeks. A sequential experimental design was used to analyze remission times while the study was in progress. This resulted in the study being stopped after analysis of the remission times of 21 pairs of patients (42 patients). Overall survival was not significantly different for the two treatment programs, since patients maintained on placebo were treated with 6-MP when relapse occurred. The activity of the known active antileukemic compound 6-MP was readily detected by this experimental design without compromise of optimal survival. Such a design should prove useful for the evaluation of new agents and also permit study of the remission maintenance activity of a compound separately from its remission inducing activity.

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