Small Cell Lung Cancer Treatment Regimens

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SMALL CELL LUNG CANCER TREATMENT REGIMENS

Clinical Trials: The NCCN recommends cancer patient participation in clinical trials as the gold standard for treatment.

Cancer therapy selection, dosing, administration, and the management of related adverse events can be a complex process that should be handled by an experienced health care team. Clinicians must choose and verify treatment options based on the individual patient; drug dose modifications and supportive care interventions should be administered accordingly. The small cell lung cancer treatment regimens below may include both U.S. Food and Drug Administration-approved and unapproved indications/regimens. These small cell lung cancer treatment regimens are provided only to supplement the latest treatment strategies.

These Cancer Treatment Guidelines are a work in progress that may be refined as often as new significant data become available. The NCCN Guidelines® are a consensus statement of its authors regarding their views of currently accepted approaches to treatment. Any clinician seeking to apply or consult any NCCN Guidelines® is expected to use independent medical judgment in the context of individual clinical circumstances to determine any patient's care or treatment. The National Comprehensive Cancer Network makes no warranties of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way.

Systemic Therapy as Primary or Adjuvant Therapy1a

Note: All recommendations are Category 2A unless otherwise indicated.

Limited Stage (maximum of 4–6 cycles)1bc

REGIMEN

DOSING

Cisplatin + etoposide2,3

Day 1: Cisplatin 60mg/m2 IV

Days 1–3: Etoposide 120mg/m2 IV.

Repeat cycle every 3 weeks for at least 4 cycles.

OR

Day 1: Cisplatin 80mg/m2 IV

Days 1–3: Etoposide 100mg/m2 IV.

Repeat cycle every 4 weeks for 4–6 cycles.

Carboplatin + etoposide4

Day 1: Carboplatin AUC 5–6mg min/mL IV

Days 1–3: Etoposide 100mg/m2 IV.

Repeat cycle every 3 weeks for 4–6 cycles.

Extensive Stage (maximum of 4–6 cycles)1

Carboplatin + etoposide5

Day 1: Carboplatin AUC 5–6mg min/mL IV

Days 1–3: Etoposide 100mg/m2 IV.

Repeat cycle every 4 weeks for 4–6 cycles.

Cisplatin + etoposide6-8

Day 1: Cisplatin 75–80mg/m2 IV

Days 1–3: Etoposide 80–100mg/m2 IV.

Repeat cycle every 3 weeks for 4–6 cycles.

OR

Days 1–3: Cisplatin 25mg/m2 IV + etoposide 100mg/m2 IV.

Repeat cycle every 3 weeks for 4-6 cycles.

Carboplatin + irinotecan9

Day 1: Carboplatin AUC 5mg min/mL IV

Days 1, 8, and 15: Irinotecan 50mg/m2 IV.

Repeat cycle every 4 weeks for 4–6 cycles.

Cisplatin + irinotecan10,11

Day 1: Cisplatin 60mg/m2 IV

Days 1, 8, and 15: Irinotecan 60mg/m2 IV.

Repeat cycle every 4 weeks for 4 cycles.

OR

Day 1 and 8: Cisplatin 30mg/m2 IV + irinotecan 65mg/m2 IV.

Repeat cycle every 3 weeks for 4–6 cycles.

Subsequent Systemic Therapy1

Relapse ≤6 months, PS 0-21

Topotecan12-14

Days 1–5: Topotecan 1.5mg/m2 IV daily over 30 minutes.

Repeat cycle every 3 weeks.

OR

Days 1–5: Topotecan 2.3mg/m2 orally once daily.

Repeat cycle every 3 weeks.

Irinotecan15

Day 1: Irinotecan 100mg/m2 IV over 90 minutes.

Repeat cycle every week.

Paclitaxel16,17

Day 1: Paclitaxel 80mg/m2 IV over 1 hour.

Repeat every week for 6 weeks, followed by a 2-week break.

Docetaxel18

Day 1: Docetaxel 100 mg/m2 IV over 1 hour.

Repeat cycle every 3 weeks.

Temozolomide19,20

Day 1–21: Temozolomide 75mg/m2 orally.

Repeat cycle every 4 weeks.

Nivolumab ± ipilimumab21

Day 1: Nivolumab 3mg/kg IV.

Repeat cycle every 2 weeks until disease progression or unacceptable toxicity.

OR

Day 1: Nivolumab 1mg/kg IV + ipilimumab 3mg/kg IV.

Repeat cycle every 3 weeks for 4 cycles, followed by nivolumab 3mg/kg IV every 2 weeks.

OR

Nivolumab 3mg/kg IV + ipilimumab 1mg/kg IV.

Repeat cycle every 3 weeks for 4 cycles, followed by nivolumab 3mg/kg IV every 2 weeks.

Vinorelbine22,23

Day 1: Vinorelbine 25–30mg/m2 IV.

Repeat cycle every week.

Etoposide24,25

Day 1–21: Etoposide 50mg/m2 orally.

Repeat cycle every 4 to 5 weeks.

Gemcitabine26,27

Days 1, 8, and 15: Gemcitabine 1,000mg/m2 IV.

Repeat cycle every 4 weeks.

Cyclophosphamide + doxorubicin + vincristine (CAV)12

Day 1: Cyclophosphamide 1,000mg/m2 IV + doxorubicin 45mg/m2 IV + vincristine 2mg IV.

Repeat cycle every 3 weeks.

Bendamustine (Category 2B)28

Days 1 and 2: Bendamustine 120mg/m2 IV.

Repeat cycle every 3 weeks for up to 6 cycles.

Relapse >6 months1

Original regimen29,30

a The regimens included are representative of the more commonly used regimens for small cell lung cancer. Other regimens may be acceptable.

b During systemic therapy + radiotherapy, cisplatin/etoposide is recommended (category 1).

c The use of myeloid growth factors is not recommended during concurrent systemic therapy plus radiotherapy (category 1 for not using GM-CSF).31

References

1. Referenced with permission from NCCN Clinical Practice Guidelines in Oncology™ Small Cell Lung Cancer. v 2.2017. Available at: http://www.nccn.org/ professionals/physician_gls/pdf/sclc.pdf. Accessed September 15, 2016.

2. Turrisi AT 3rd, Kim K, Blum R, et al. Twice-daily compared with once-daily thoracic radiotherapy in limited small-cell lung cancer treated concurrently with cisplatin and etoposide. N Engl J Med. 1999;340(4):265–271.

3. Saito H, Takada Y, Ichinose Y, et al. Phase II study of etoposide and cisplatin with concurrent twice-daily thoracic radiotherapy followed by irinotecan and cisplatin in patients with limited-disease small-cell lung cancer: West Japan Thoracic Oncology Group 9902. J Clin Oncol. 2006;24(33): 5247–5252.

4. Skarlos DV, Samantas E, Briassoulis E, et al. Randomized comparison of early versus late hyperfractionated thoracic irradiation concurrently with chemotherapy in limited disease small-cell lung cancer: a randomized phase II study of the Hellenic Cooperative Oncology Group (HeCOG). Ann Oncol. 2001;12(9):1231–1238.

5. Okamoto H, Watanabe K, Nishiwaki Y, et al. Phase II study of area under the plasma-concentration-versus-time curve-based carboplatin plus standard-dose intravenous etoposide in elderly patients with small cell lung cancer. J Clin Oncol. 1999;17(11):3540–3545.

6. Spigel DR, Townley PM, Waterhouse DM, et al. Randomized phase II study of bevacizumab in combination with chemotherapy in previously untreated extensive-stage small-cell lung cancer: results from the SALUTE trial. J Clin Oncol. 2011;29:2215–2222.

7. Niell HB, Herndon JE, Miller AA, et al. Randomized phase III Intergroup trial of etoposide with extensive-stage small-cell lung cancer: Cancer and Leukemia Group B trial 9732. J Clin Oncol. 2005;23:3752–3759.

8. Evans WK, Shepherd FA, Feld R, et al. VP-16 and cisplatin as first-line therapy for small-cell lung cancer. J Clin Oncol. 1985;3(11): 1471–1477.

9. Schmittel A, Fischer von Weikersthal L, Sebastian M, et al. A randomized phase II trial of irinotecan plus carboplatin versus etoposide plus carboplatin treatment in patients with extended disease small-cell lung cancer. Ann Oncol. 2006;17:663–667.

10. Noda K, Nishiwaki Y, Kawahara M, et al. Irinotecan plus cisplatin compared with etoposide plus cisplatin for extensive small-cell lung cancer. N Engl J Med. 2002;346(2):85–91.

11. Hanna N, Bunn Jr. PA, Langer C, et al. Randomized phase III trial comparing irinotecan/cisplatin with etoposide/cisplatin in patients with previously untreated extensive-stage disease small-cell lung cancer. J Clin Oncol. 2006;24(13):2038–2043.

12. von Pawel J, Schiller JH, Shepherd FA, et al. Topotecan versus cyclophosphamide, doxorubicin, and vincristine for the treatment of recurrent small-cell lung cancer. J Clin Oncol. 1999;17(2):658–667.

13. O'Brien ME, Ciuleanu TE, Tsekov H, et al. Phase III trial comparing supportive care alone with supportive care with oral topotecan in patients with relapsed small-cell lung cancer. J Clin Oncol. 2006;24(34):5441–5447.

14. Eckardt JR, von Pawel J, Pujol JL, et al. Phase III study of oral compared with intravenous topotecan as second-line therapy in small-cell lung cancer. J Clin Oncol. 2007;25(15):2086–2092.

15. Masuda N, Fukuoka M, Kusunoki Y, et al. CPT-11: a new derivative of camptothecin for the treatment of refractory or relapsed small-cell lung cancer. J Clin Oncol. 1992; 10:1225–1229.

16. Smit EF, Fokkema E, Biesma B, et al. A phase II study of paclitaxel in heavily pretreated patients with small-cell lung cancer. Br J Cancer. 1998;77:347–351.

17. Yamamoto N, Tsurutani J, Yoshimura N, et al. Phase II study of weekly paclitaxel for relapsed and refractory small cell lung cancer. Anticancer Res. 2006;26:777–781.

18. Smyth JF, Smith IE, Sessa C, et al. Activity of docetaxel (Taxotere) in small cell lung cancer. Eur J Cancer. 1994; 30A:1058–1060.

19. Pietanza MC, Kadota K, Huberman K, et al. Phase II trial of temozolomide with relapsed sensitive or refractory small cell lung cancer, with assessment of methylguanine-DNA methyltransferase as a potential biomarker. Clin Cancer Res. 2012;18:1138–1145.

20. Zauderer MG, Drilon A, Kadota K, et al. Trial of a 5-day dosing regimen of temozolomide in patients with relapsed small cell lung cancers with assessment of methylguanine-DNA methyltransferase. Lung Cancer. 2014;86:237–240.

21. Antonia SJ, López-Martin JA, Bendell J, et al. Nivolumab alone and nivolumab plus ipilimumab in recurrent small-cell lung cancer (Checkmate 032): a multicentre, open-label phase 1/2 trial. Lancet Oncol. 2016;17:883–895.

22. Jassem J, Karnicka-Mlodkowska H, van Pottelsberghe C, et al. Phase II study of vinorelbine (Navelbine) in previously treated small cell lung cancer patients. Eur J Cancer. 1993;29A: 1720–1722.

23. Furuse K, Kuboa K, Kawahara M, et al. Phase II study of vinorelbine in heavily previously treated small cell lung cancer. Oncology. 1996;53:169–172.

24. Einhorn LH, Pennington K, McClean J. Phase II trial of daily oral VP-16 in refractory small cell lung cancer. Semin Oncol. 1990; 17:32–35.

25. Johnson DH, Greco FA, Strupp J, et al. Prolonged administration of oral etoposide in patients with relapsed or refractory small-cell lung cancer: a phase II trial. J Clin Oncol. 1990; 8:1613–1617.

26. Van der Lee I, Smit EF, van Putten JW, et al. Single-agent gemcitabine in patients with resistant small-cell lung cancer. Ann Oncol. 2001;12:557–561.

27. Masters GA, Declerck L, Blanke C, et al. Phase II trial of gemcitabine in refractory or relapsed small-cell lung cancer. J Clin Oncol. 2003;21:1550–1555.

28. Lammers PE, Shyr Y, Li CI, et al. Phase II study of bendamustine in relapsed chemotherapy sensitive or resistant small-cell lung cancer. J Thorac Oncol. 2014;9:559–562.

29. Postmus PE, Berendsen HH, van Zandwijk N, et al. Retreatment with the induction regimen in small cell lung cancer relapsing after an initial response to short term chemotherapy. Eur J Cancer Clin Oncol. 1987;23:1409–1411.

30. Giaccone G, Ferrati P, Donadio M, et al. Reinduction chemotherapy in small cell lung cancer. Eur J Cancer Clin Oncol. 1987;23: 1697–1699.

31. Bunn PA, Crowley J, Kelly K, et al. Chemoradiotherapy with or without granulocyte-macrophage colony-stimulating factor in the treatment of limited-stage small-cell lung cancer: a prospective phase III randomized study of the Southwest Oncology Group. J Clin Oncol. 1995;13:1632–1641.

10/2016

© 2016 Haymarket Media, Inc.


Lung Cancer Drug Monographs

Respiratory And Thoracic Cancers

ABRAXANE ALECENSA ALIMTA
AVASTIN BLEOMYCIN CYRAMZA
DOXORUBICIN HCL DOXORUBICIN HCL SOLUTION ETOPOPHOS
ETOPOSIDE CAPSULES GEMZAR GILOTRIF
HYCAMTIN HYCAMTIN CAPSULES IRESSA
KEYTRUDA METHOTREXATE FOR INJECTION METHOTREXATE INJECTION
MUSTARGEN NAVELBINE OPDIVO
PHOTOFRIN PORTRAZZA TAGRISSO
TARCEVA TAXOL TAXOTERE
TECENTRIQ TOPOSAR TREXALL
XALKORI ZYKADIA

Data provided by the Monthly Prescribing Reference (MPR) Hematology/Oncology Edition.

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