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Neuroblastoma is a rare cancer but is the most common malignancy of infancy.
Cisplatin & Pemetrexed -- current version
Regimen
| FDA-recommended dose |
| Study | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|
| Vogelzang et al. 2003 (JMCH) | Phase 3 (E-RT) | Cisplatin | Seems to have superior OS |
| Zalcman et al. 2016 (MAPS) | Phase 3 (C) | PCB | Seems to have inferior OS |
| Grosso et al. 2017 (LUME-Meso) | Phase 2/3 (C) | Cisplatin, Nintedanib, Pemetrexed | Seems not superior (*) |
Note: JMCH did not specify the total number of cycles and some patients did receive more than 6 cycles. Reported efficacy for LUME-Meso is based on the 2019 update.
Chemotherapy
- Cisplatin (Platinol) 75 mg/m2 IV over 2 hours once on day 1, given second, 30 minutes after pemetrexed
- Pemetrexed (Alimta) 500 mg/m2 IV over 10 minutes once on day 1, given first
Supportive medications
- Folic acid 350 to 1000 mcg PO once per day, starting 1 to 3 weeks before Pemetrexed (Alimta), to continue throughout therapy
- Cyanocobalamin (Vitamin B12) 1000 mcg IM once 1 to 3 weeks before Pemetrexed (Alimta), then 1000 mcg IM once every 9 weeks
- Dexamethasone (Decadron) (dose not specified by reference) the day before, the day of, and day after Pemetrexed (Alimta)
21-day cycle for up to 6 cycles (see note)
References
- JMCH: Vogelzang NJ, Rusthoven JJ, Symanowski J, Denham C, Kaukel E, Ruffie P, Gatzemeier U, Boyer M, Emri S, Manegold C, Niyikiza C, Paoletti P. Phase III study of pemetrexed in combination with cisplatin versus cisplatin alone in patients with malignant pleural mesothelioma. J Clin Oncol. 2003 Jul 15;21(14):2636-44. link to original article contains dosing details in manuscript PubMed
- Update: Manegold C, Symanowski J, Gatzemeier U, Reck M, von Pawel J, Kortsik C, Nackaerts K, Lianes P, Vogelzang NJ. Second-line (post-study) chemotherapy received by patients treated in the phase III trial of pemetrexed plus cisplatin versus cisplatin alone in malignant pleural mesothelioma. Ann Oncol. 2005 Jun;16(6):923-7. Epub 2005 Apr 11. link to original article PubMed
- MAPS: Zalcman G, Mazieres J, Margery J, Greillier L, Audigier-Valette C, Moro-Sibilot D, Molinier O, Corre R, Monnet I, Gounant V, Rivière F, Janicot H, Gervais R, Locher C, Milleron B, Tran Q, Lebitasy MP, Morin F, Creveuil C, Parienti JJ, Scherpereel A; French Cooperative Thoracic Intergroup (IFCT). Bevacizumab for newly diagnosed pleural mesothelioma in the Mesothelioma Avastin Cisplatin Pemetrexed Study (MAPS): a randomised, controlled, open-label, phase 3 trial. Lancet. 2016 Apr 2;387(10026):1405-14. Epub 2015 Dec 21. Erratum in: Lancet. 2016 Apr 2;387(10026):e24. link to original article contains dosing details in abstract PubMed
- LUME-Meso: Grosso F, Steele N, Novello S, Nowak AK, Popat S, Greillier L, John T, Leighl NB, Reck M, Taylor P, Planchard D, Sørensen JB, Socinski MA, von Wangenheim U, Loembé AB, Barrueco J, Morsli N, Scagliotti G. Nintedanib plus pemetrexed/cisplatin in patients with malignant pleural mesothelioma: Phase II results from the randomized, placebo-controlled LUME-Meso trial. J Clin Oncol. 2017 Nov 1;35(31):3591-3600. Epub 2017 Sep 11. link to original article contains dosing details in manuscript PubMed
- Update: Scagliotti GV, Gaafar R, Nowak AK, Nakano T, van Meerbeeck J, Popat S, Vogelzang NJ, Grosso F, Aboelhassan R, Jakopovic M, Ceresoli GL, Taylor P, Orlandi F, Fennell DA, Novello S, Scherpereel A, Kuribayashi K, Cedres S, Sørensen JB, Pavlakis N, Reck M, Velema D, von Wangenheim U, Kim M, Barrueco J, Tsao AS. Nintedanib in combination with pemetrexed and cisplatin for chemotherapy-naive patients with advanced malignant pleural mesothelioma (LUME-Meso): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet Respir Med. 2019 Jul;7(7):569-580. Epub 2019 May 15. link to original article PubMed
Cisplatin & Pemetrexed -- proposed version
Regimen
| FDA-recommended dose | NCCN Category 1 |
| Study | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|
| Vogelzang et al. 2003 (JMCH) | Phase 3 (E-RT) | Cisplatin | Seems to have superior OS |
| Zalcman et al. 2016 (MAPS) | Phase 3 (C) | PCB | Seems to have inferior OS |
| Grosso et al. 2017 (LUME-Meso) | Phase 2/3 (C) | Cisplatin, Nintedanib, Pemetrexed | Seems not superior (*) |
Note: JMCH did not specify the total number of cycles and some patients did receive more than 6 cycles. Reported efficacy for LUME-Meso is based on the 2019 update.
Chemotherapy
- Cisplatin (Platinol) 75 mg/m2 IV over 2 hours once on day 1, given second, 30 minutes after pemetrexed
- Pemetrexed (Alimta) 500 mg/m2 IV over 10 minutes once on day 1, given first
Supportive medications
- Folic acid 350 to 1000 mcg PO once per day, starting 1 to 3 weeks before Pemetrexed (Alimta), to continue throughout therapy
- Cyanocobalamin (Vitamin B12) 1000 mcg IM once 1 to 3 weeks before Pemetrexed (Alimta), then 1000 mcg IM once every 9 weeks
- Dexamethasone (Decadron) (dose not specified by reference) the day before, the day of, and day after Pemetrexed (Alimta)
21-day cycle for up to 6 cycles (see note)
References
- JMCH: Vogelzang NJ, Rusthoven JJ, Symanowski J, Denham C, Kaukel E, Ruffie P, Gatzemeier U, Boyer M, Emri S, Manegold C, Niyikiza C, Paoletti P. Phase III study of pemetrexed in combination with cisplatin versus cisplatin alone in patients with malignant pleural mesothelioma. J Clin Oncol. 2003 Jul 15;21(14):2636-44. link to original article contains dosing details in manuscript PubMed
- Update: Manegold C, Symanowski J, Gatzemeier U, Reck M, von Pawel J, Kortsik C, Nackaerts K, Lianes P, Vogelzang NJ. Second-line (post-study) chemotherapy received by patients treated in the phase III trial of pemetrexed plus cisplatin versus cisplatin alone in malignant pleural mesothelioma. Ann Oncol. 2005 Jun;16(6):923-7. Epub 2005 Apr 11. link to original article PubMed
- MAPS: Zalcman G, Mazieres J, Margery J, Greillier L, Audigier-Valette C, Moro-Sibilot D, Molinier O, Corre R, Monnet I, Gounant V, Rivière F, Janicot H, Gervais R, Locher C, Milleron B, Tran Q, Lebitasy MP, Morin F, Creveuil C, Parienti JJ, Scherpereel A; French Cooperative Thoracic Intergroup (IFCT). Bevacizumab for newly diagnosed pleural mesothelioma in the Mesothelioma Avastin Cisplatin Pemetrexed Study (MAPS): a randomised, controlled, open-label, phase 3 trial. Lancet. 2016 Apr 2;387(10026):1405-14. Epub 2015 Dec 21. Erratum in: Lancet. 2016 Apr 2;387(10026):e24. link to original article contains dosing details in abstract PubMed
- LUME-Meso: Grosso F, Steele N, Novello S, Nowak AK, Popat S, Greillier L, John T, Leighl NB, Reck M, Taylor P, Planchard D, Sørensen JB, Socinski MA, von Wangenheim U, Loembé AB, Barrueco J, Morsli N, Scagliotti G. Nintedanib plus pemetrexed/cisplatin in patients with malignant pleural mesothelioma: Phase II results from the randomized, placebo-controlled LUME-Meso trial. J Clin Oncol. 2017 Nov 1;35(31):3591-3600. Epub 2017 Sep 11. link to original article contains dosing details in manuscript PubMed
- Update: Scagliotti GV, Gaafar R, Nowak AK, Nakano T, van Meerbeeck J, Popat S, Vogelzang NJ, Grosso F, Aboelhassan R, Jakopovic M, Ceresoli GL, Taylor P, Orlandi F, Fennell DA, Novello S, Scherpereel A, Kuribayashi K, Cedres S, Sørensen JB, Pavlakis N, Reck M, Velema D, von Wangenheim U, Kim M, Barrueco J, Tsao AS. Nintedanib in combination with pemetrexed and cisplatin for chemotherapy-naive patients with advanced malignant pleural mesothelioma (LUME-Meso): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet Respir Med. 2019 Jul;7(7):569-580. Epub 2019 May 15. link to original article PubMed
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