Difference between revisions of "Rhabdomyosarcoma, pediatric"
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+ | =Upfront Therapy= | ||
+ | ==COG ARST0431== | ||
+ | ===Protocol {{#subobject:9a3f8d|Variant=1}}=== | ||
+ | {| class="wikitable sortable" style="width: 60%; text-align:center;" | ||
+ | !style="width: 33%"|Study | ||
+ | !style="width: 33%"|Years of enrollment | ||
+ | !style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
+ | |- | ||
+ | |[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5070550/ Weigel et al. 2015 (COG ARST0431)] | ||
+ | |2006-2008 | ||
+ | | style="background-color:#91cf61" |Phase 2 | ||
+ | |- | ||
+ | |} | ||
+ | |||
+ | ====Vincristine and Irinotecan==== | ||
+ | Weeks 1, 4, 20, 23, 47, & 50 | ||
+ | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
+ | **Age ≥ 3 years: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 | ||
+ | **Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 | ||
+ | **Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1 | ||
+ | Administer [[Vincristine (Oncovin)]] before [[Irinotecan (Camptosar)]] | ||
+ | *[[Irinotecan (Camptosar)]] 50 mg/m<sup>2</sup> (maximum dose of 100 mg/day) IV over 60 minutes once per day on days 1 through 5 | ||
+ | |||
+ | ====Vincristine Monotherapy==== | ||
+ | Weeks 2, 3, 5, 8, 12, 16, 21, 22, 24, 29, 33, 42, 43, 48, & 50 | ||
+ | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
+ | **Age ≥ 3 years: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 | ||
+ | **Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 | ||
+ | **Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1 | ||
+ | ====Off Chemotherapy Weeks==== | ||
+ | Weeks 6, 10, 14, 18, 19, 25, 27, 31, 34, 36, 37, 39, 40, 45, 46, 49, 52, 53, & 54 | ||
+ | ====Vincristine, Doxorubicin, and Cyclophosphamide==== | ||
+ | Weeks 7, 11, 15, 28, & 32 | ||
+ | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
+ | **Age ≥ 3 years: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 | ||
+ | **Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 | ||
+ | **Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1 | ||
+ | *[[Doxorubicin (Adriamycin)]] by the following age-based criteria: | ||
+ | **Age ≥ 1 year: 37.5 mg/m<sup>2</sup> (Total dose per week of 75 mg/m<sup>2</sup>) IV over 24 hours once per day on days 1 through 2 | ||
+ | **Age < 1 year: 18.75 mg/m<sup>2</sup> IV over 24 hours once per day on days 1 through 2 | ||
+ | *[[Cyclophosphamide (Cytoxan)]] by the following age-based criteria: | ||
+ | **Age ≥ 3 years: 1200 mg/m<sup>2</sup> IV over 1 hour once per day on day 1 | ||
+ | **Age < 3 years: 40mg/kg IV over 1 hour once per day on day 1 | ||
+ | *[[Mesna (Mesnex)]] by the following age-based criteria: | ||
+ | **Age ≥ 3 years: 240 mg/m<sup>2</sup> at hour 0, 4, and 8 from the start of each [[Cyclophosphamide (Cytoxan)]] infusion on days 1 | ||
+ | **Age < 3 years: 8 mg/kg at hour 0, 4, and 8 from the start of each [[Cyclophosphamide (Cytoxan)]] infusion on days 1 | ||
+ | |||
+ | |||
+ | ====Ifosfamide and Etoposide==== | ||
+ | Weeks 9, 13, 17, 26, & 30 | ||
+ | *[[Ifosfamide (Ifex)]] by the following age-based criteria: | ||
+ | **Age ≥ 1 year: 1800 mg/m<sup>2</sup> IV over 1 hour once per day on days 1 through 5 | ||
+ | **Age < 1 year: 900 mg/m<sup>2</sup> IV over 1 hour once per day on days 1 through 5 | ||
+ | *[[Mesna (Mesnex)]] by the following age-based criteria: | ||
+ | **Age ≥ 3 years: 360 mg/m<sup>2</sup> at hour 0, 4, and 8 from the start of each [[Ifosfamide (Ifex)]] infusion on days 1 through 5 | ||
+ | **Age < 3 years: 180 mg/m<sup>2</sup> at hour 0, 4, and 8 from the start of each [[Ifosfamide (Ifex)]] infusion on days 1 through 5 | ||
+ | *[[Etoposide (Vepesid)]] by the following age-based criteria: | ||
+ | **Age ≥ 1 year: 100 mg/m<sup>2</sup> IV over 30 to 60 minutes once per day on days 1 through 5 | ||
+ | **Age < 1 year: 50 mg/m<sup>2</sup> IV over 30 to 60 minutes once per day on days 1 through 5 | ||
+ | |||
+ | ====Vincristine, Dactinomycin, and Cyclophosphamide==== | ||
+ | Weeks 35, 38, 41, & 44 | ||
+ | *[[Vincristine (Oncovin)]] by the following age-based criteria: | ||
+ | **Age ≥ 3 years: 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push over 1 minute once on day 1 | ||
+ | **Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1 | ||
+ | **Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1 | ||
+ | *[[Dactinomycin (Cosmegen)]] by the following age-based criteria: | ||
+ | **Age ≥ 1 year: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1 | ||
+ | **Age < 1 year: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1 | ||
+ | *[[Cyclophosphamide (Cytoxan)]] by the following age-based criteria: | ||
+ | **Age ≥ 3 years: 1200 mg/m<sup>2</sup> IV over 1 hour once per day on day 1 | ||
+ | **Age < 3 years: 40mg/kg IV over 1 hour once per day on day 1 | ||
+ | *[[Mesna (Mesnex)]] by the following age-based criteria: | ||
+ | **Age ≥ 3 years: 240 mg/m<sup>2</sup> at hour 0, 4, and 8 from the start of each [[Cyclophosphamide (Cytoxan)]] infusion on days 1 | ||
+ | **Age < 3 years: 8 mg/kg at hour 0, 4, and 8 from the start of each [[Cyclophosphamide (Cytoxan)]] infusion on days 1 | ||
+ | |||
+ | =====References===== | ||
+ | # '''COG ARST0431:''' Weigel BJ, Lyden E, Anderson JR, Meyer WH, Parham DM, Rodeberg DA, Michalski JM, Hawkins DS, Arndt CAS. Intensive Multiagent Therapy, Including Dose-Compressed Cycles of Ifosfamide/Etoposide and Vincristine/Doxorubicin/Cyclophosphamide, Irinotecan, and Radiation, in Patients with High-Risk Rhabdomyosarcoma: A Report from the Children's Oncology Group. Journal of Clinical Oncology. 2016 Oct;34(2):117-122. [https://doi.org/10.1200/jco.2015.63.4048 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5070550/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/26503200/ PubMed] NCT00354744 | ||
Revision as of 23:02, 18 May 2022
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Upfront Therapy
COG ARST0431
Protocol
Study | Years of enrollment | Evidence |
---|---|---|
Weigel et al. 2015 (COG ARST0431) | 2006-2008 | Phase 2 |
Vincristine and Irinotecan
Weeks 1, 4, 20, 23, 47, & 50
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
Administer Vincristine (Oncovin) before Irinotecan (Camptosar)
- Irinotecan (Camptosar) 50 mg/m2 (maximum dose of 100 mg/day) IV over 60 minutes once per day on days 1 through 5
Vincristine Monotherapy
Weeks 2, 3, 5, 8, 12, 16, 21, 22, 24, 29, 33, 42, 43, 48, & 50
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
Off Chemotherapy Weeks
Weeks 6, 10, 14, 18, 19, 25, 27, 31, 34, 36, 37, 39, 40, 45, 46, 49, 52, 53, & 54
Vincristine, Doxorubicin, and Cyclophosphamide
Weeks 7, 11, 15, 28, & 32
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
- Doxorubicin (Adriamycin) by the following age-based criteria:
- Age ≥ 1 year: 37.5 mg/m2 (Total dose per week of 75 mg/m2) IV over 24 hours once per day on days 1 through 2
- Age < 1 year: 18.75 mg/m2 IV over 24 hours once per day on days 1 through 2
- Cyclophosphamide (Cytoxan) by the following age-based criteria:
- Age ≥ 3 years: 1200 mg/m2 IV over 1 hour once per day on day 1
- Age < 3 years: 40mg/kg IV over 1 hour once per day on day 1
- Mesna (Mesnex) by the following age-based criteria:
- Age ≥ 3 years: 240 mg/m2 at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on days 1
- Age < 3 years: 8 mg/kg at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on days 1
Ifosfamide and Etoposide
Weeks 9, 13, 17, 26, & 30
- Ifosfamide (Ifex) by the following age-based criteria:
- Age ≥ 1 year: 1800 mg/m2 IV over 1 hour once per day on days 1 through 5
- Age < 1 year: 900 mg/m2 IV over 1 hour once per day on days 1 through 5
- Mesna (Mesnex) by the following age-based criteria:
- Age ≥ 3 years: 360 mg/m2 at hour 0, 4, and 8 from the start of each Ifosfamide (Ifex) infusion on days 1 through 5
- Age < 3 years: 180 mg/m2 at hour 0, 4, and 8 from the start of each Ifosfamide (Ifex) infusion on days 1 through 5
- Etoposide (Vepesid) by the following age-based criteria:
- Age ≥ 1 year: 100 mg/m2 IV over 30 to 60 minutes once per day on days 1 through 5
- Age < 1 year: 50 mg/m2 IV over 30 to 60 minutes once per day on days 1 through 5
Vincristine, Dactinomycin, and Cyclophosphamide
Weeks 35, 38, 41, & 44
- Vincristine (Oncovin) by the following age-based criteria:
- Age ≥ 3 years: 1.5 mg/m2 (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age ≥ 1 year to < 3 years: 0.05 mg/kg (maximum dose of 2 mg) IV push over 1 minute once on day 1
- Age < 1 year: 0.025 mg/kg IV push over 1 minute once on day 1
- Dactinomycin (Cosmegen) by the following age-based criteria:
- Age ≥ 1 year: 0.045 mg/kg (maximum dose of 2.5 mg) IV push over 1 to 5 minutes once per day on day 1
- Age < 1 year: 0.025 mg/kg IV over 1 to 5 minutes once per day on day 1
- Cyclophosphamide (Cytoxan) by the following age-based criteria:
- Age ≥ 3 years: 1200 mg/m2 IV over 1 hour once per day on day 1
- Age < 3 years: 40mg/kg IV over 1 hour once per day on day 1
- Mesna (Mesnex) by the following age-based criteria:
- Age ≥ 3 years: 240 mg/m2 at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on days 1
- Age < 3 years: 8 mg/kg at hour 0, 4, and 8 from the start of each Cyclophosphamide (Cytoxan) infusion on days 1
References
- COG ARST0431: Weigel BJ, Lyden E, Anderson JR, Meyer WH, Parham DM, Rodeberg DA, Michalski JM, Hawkins DS, Arndt CAS. Intensive Multiagent Therapy, Including Dose-Compressed Cycles of Ifosfamide/Etoposide and Vincristine/Doxorubicin/Cyclophosphamide, Irinotecan, and Radiation, in Patients with High-Risk Rhabdomyosarcoma: A Report from the Children's Oncology Group. Journal of Clinical Oncology. 2016 Oct;34(2):117-122. link to original article link to PMC article PubMed NCT00354744