Skip to main content

Advertisement

SpringerLink
Log in

Meta-analysis of published efficacy and safety data for docetaxel in second-line treatment of patients with advanced non-small-cell lung cancer

  • Original Article
  • Published:
Cancer Chemotherapy and Pharmacology Aims and scope Submit manuscript

Abstract

Purpose

To gain a better understanding of the impact of dose and other prognostic factors on safety and efficacy of docetaxel in second-line non-small-cell lung cancer patients.

Methods

A model-based meta‐analysis (MBMA) of a published docetaxel monotherapy data in 6085 second‐line non-small-cell lung cancer patients from 46 trials was conducted.

Results

The logit of grade 3/4 neutropenia incidence was a linear function of dose, with a 5 % increase in the odds of neutropenia per mg/m2 increase in dose [odds ratio (OR) 1.05, 95 % confidence interval (CI) 1.04–1.06], and a Japanese study effect (OR 17.1, 95 % CI 6.05–48.4). The logit of overall response rate (ORR) was a linear function of cumulative dose (0.4 % increase in the odds of response per mg/m2 increase; OR 1.004, 95 % CI 1.001–1.008) and median population age (OR 1.08 per year, 95 % CI 1.02–1.15). A Japanese study effect was identified for overall survival (OS) in addition to prognostic factors identified by a previous meta-analysis.

Conclusions

This current MBMA identified docetaxel dose–response relationships for both neutropenia and ORR, an effect of age on ORR, and Japanese study effects on both neutropenia and OS.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2
Fig. 3
Fig. 4

Similar content being viewed by others

References

  1. Molina JR, Yang P, Cassivi SD, Schild SE, Adjei AA (2008) Non-small cell lung cancer: epidemiology, risk factors, treatment, and survivorship. Mayo Clin Proc 83(5):584–594. doi:10.4065/83.5.584

    Article  PubMed Central  PubMed  Google Scholar 

  2. Stinchcombe TE, Socinski MA (2008) Considerations for second-line therapy of non-small cell lung cancer. Oncologist 13(Suppl 1):28–36. doi:10.1634/theoncologist.13-S1-28

    Article  CAS  PubMed  Google Scholar 

  3. Mandema JW, Gibbs M, Boyd RA, Wada DR, Pfister M (2011) Model-based meta-analysis for comparative efficacy and safety: application in drug development and beyond. Clin Pharmacol Ther 90(6):766–769. doi:10.1038/clpt.2011.242

    Article  CAS  PubMed  Google Scholar 

  4. Engels FK, Verweij J (2005) Docetaxel administration schedule: from fever to tears? A review of randomised studies. Eur J Cancer (Oxford, England: 1990) 41(8):1117–1126. doi:10.1016/j.ejca.2005.02.016

    Article  CAS  Google Scholar 

  5. Bruno R, Hille D, Riva A, Vivier N, ten Bokkel Huinnink WW, van Oosterom AT, Kaye SB, Verweij J, Fossella FV, Valero V, Rigas JR, Seidman AD, Chevallier B, Fumoleau P, Burris HA, Ravdin PM, Sheiner LB (1998) Population pharmacokinetics/pharmacodynamics of docetaxel in phase II studies in patients with cancer. J Clin Oncol 16(1):187–196

    CAS  PubMed  Google Scholar 

  6. Harvey V, Mouridsen H, Semiglazov V, Jakobsen E, Voznyi E, Robinson BA, Groult V, Murawsky M, Cold S (2006) Phase III trial comparing three doses of docetaxel for second-line treatment of advanced breast cancer. J Clin Oncol 24(31):4963–4970. doi:10.1200/jco.2005.05.0294

    Article  CAS  PubMed  Google Scholar 

  7. Kerbel RS, Kamen BA (2004) The anti-angiogenic basis of metronomic chemotherapy. Nat Rev Cancer 4(6):423–436. doi:10.1038/nrc1369

    Article  CAS  PubMed  Google Scholar 

  8. Clarke SJ, Rivory LP (1999) Clinical pharmacokinetics of docetaxel. Clin Pharmacokinet 36(2):99–114. doi:10.2165/00003088-199936020-00002

    Article  CAS  PubMed  Google Scholar 

  9. Friberg LE, Henningsson A, Maas H, Nguyen L, Karlsson MO (2002) Model of chemotherapy-induced myelosuppression with parameter consistency across drugs. J Clin Oncol 20(24):4713–4721

    Article  PubMed  Google Scholar 

  10. Haidich AB (2010) Meta-analysis in medical research. Hippokratia 14(Suppl 1):29–37

    PubMed Central  CAS  PubMed  Google Scholar 

  11. Shen G, Bian G, Yu H, Gao M, Kang D, Shen G, Hu S (2014) Comparison between cisplatin plus vinorelbine and cisplatin plus docetaxel in the treatment of advanced non-small-cell lung cancer: a meta-analysis of randomized controlled trials. Mol Clin Oncol 2(1):146–150. doi:10.3892/mco.2013.210

    PubMed Central  CAS  PubMed  Google Scholar 

  12. Di BS, Wei KP, Tian JH, Xiao XJ, Li Y, Zhang XH, Yu Q, Yang KH, Ge L, Huang WH, Zhang FW (2014) Effectiveness and safety of pemetrexed versus docetaxel as a treatment for advanced non-small cell lung cancer: a systematic review and meta-analysis. Asian Pac J Cancer Prev APJCP 15(8):3419–3424

    Article  PubMed  Google Scholar 

  13. Li X, Wang H, Lin W, Xu Q (2014) Efficacy of combining targeted therapy with pemetrexed or docetaxel as second-line treatment in patients with advanced non-small-cell lung cancer: a meta-analysis of 14 randomized controlled trials. Curr Med Res Opin. doi:10.1185/03007995.2014.909392

    Google Scholar 

  14. Des Guetz G, Uzzan B, Nicolas P, Valeyre D, Sebbane G, Morere JF (2012) Comparison of the efficacy and safety of single-agent and doublet chemotherapy in advanced non-small cell lung cancer in the elderly: a meta-analysis. Crit Rev Oncol/Hematol 84(3):340–349. doi:10.1016/j.critrevonc.2012.03.007

    Article  Google Scholar 

  15. Qi WX, Shen Z, Yao Y (2012) Meta-analysis of docetaxel-based doublet versus docetaxel alone as second-line treatment for advanced non-small-cell lung cancer. Cancer Chemother Pharmacol 69(1):99–106. doi:10.1007/s00280-011-1678-9

    Article  CAS  PubMed  Google Scholar 

  16. Di Maio M, Chiodini P, Georgoulias V, Hatzidaki D, Takeda K, Wachters FM, Gebbia V, Smit EF, Morabito A, Gallo C, Perrone F, Gridelli C (2009) Meta-analysis of single-agent chemotherapy compared with combination chemotherapy as second-line treatment of advanced non-small-cell lung cancer. J Clin Oncol 27(11):1836–1843. doi:10.1200/JCO.2008.17.5844

    Article  PubMed  Google Scholar 

  17. Di Maio M, Perrone F, Chiodini P, Gallo C, Camps C, Schuette W, Quoix E, Tsai CM, Gridelli C (2007) Individual patient data meta-analysis of docetaxel administered once every 3 weeks compared with once every week second-line treatment of advanced non-small-cell lung cancer. J Clin Oncol 25(11):1377–1382. doi:10.1200/JCO.2006.09.8251

    Article  PubMed  Google Scholar 

  18. Maio M, Lama N, Morabito A, Smit EF, Georgoulias V, Takeda K, Quoix E, Hatzidaki D, Wachters FM, Gebbia V, Tsai CM, Camps C, Schuette W, Chiodini P, Piccirillo MC, Perrone F, Gallo C, Gridelli C (2010) Clinical assessment of patients with advanced non-small-cell lung cancer eligible for second-line chemotherapy a prognostic score from individual data of nine randomised trials. Eur J Cancer (Oxford, England: 1990) 46(4):735–743. doi:10.1016/j.ejca.2009.12.013

    Article  Google Scholar 

  19. Di Maio M, Krzakowski M, Fougeray R, Kowalski DM, Gridelli C (2012) Prognostic score for second-line chemotherapy of advanced non-small-cell lung cancer: external validation in a phase III trial comparing vinflunine with docetaxel. Lung Cancer 77(1):116–120. doi:10.1016/j.lungcan.2012.01.013

    Article  PubMed  Google Scholar 

  20. Lu D, Joshi A, Li H, Zhang N, Ren MM, Gao Y, Wada R, Jin JY (2014) Model-based meta-analysis for quantifying Paclitaxel dose response in cancer patients. CPT Pharmacomet Syst Pharmacol. doi:10.1038/psp.2014.14

    Google Scholar 

  21. Sally Green JPH, Alderson P, Clarke M, Mulrow CD, Oxman AD (2009) Cochrane Handbook for Systematic Reviews of Interventions. In: Higgins JPT, Green s (eds) The cochrane collaborations. Wiley, New York

    Google Scholar 

  22. Moher D, Liberati A, Tetzlaff J, Altman DG, Group P (2009) Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. PLoS Med 6(7):e1000097. doi:10.1371/journal.pmed.1000097

    Article  PubMed Central  PubMed  Google Scholar 

  23. Takeda K, Negoro S, Tamura T, Nishiwaki Y, Kudoh S, Yokota S, Matsui K, Semba H, Nakagawa K, Takada Y, Ando M, Shibata T, Saijo N (2009) Phase III trial of docetaxel plus gemcitabine versus docetaxel in second-line treatment for non-small-cell lung cancer: results of a Japan Clinical Oncology Group trial (JCOG0104). Ann Oncol 20(5):835–841. doi:10.1093/annonc/mdn705

    Article  CAS  PubMed  Google Scholar 

  24. Maruyama R, Nishiwaki Y, Tamura T, Yamamoto N, Tsuboi M, Nakagawa K, Shinkai T, Negoro S, Imamura F, Eguchi K, Takeda K, Inoue A, Tomii K, Harada M, Masuda N, Jiang H, Itoh Y, Ichinose Y, Saijo N, Fukuoka M (2008) Phase III study, V-15-32, of gefitinib versus docetaxel in previously treated Japanese patients with non-small-cell lung cancer. J Clin Oncol 26(26):4244–4252. doi:10.1200/JCO.2007.15.0185

    Article  CAS  PubMed  Google Scholar 

  25. Wada R (2013) Technical challenges in modeling Kaplan‐Meier survival curves. In: Paper presented at the American Conference on Pharmacometrics, Ft. Lauderdale, FL, May 2013

  26. Quartino AL, Friberg LE, Karlsson MO (2012) A simultaneous analysis of the time-course of leukocytes and neutrophils following docetaxel administration using a semi-mechanistic myelosuppression model. Invest New Drugs 30(2):833–845. doi:10.1007/s10637-010-9603-3

    Article  CAS  PubMed  Google Scholar 

  27. Perng RP, Shih JF, Chen YM, Chou KC, Lee YC, Tsai CM (2000) A phase II study of single-agent docetaxel chemotherapy for non-small cell lung cancer. Jpn J Clin Oncol 30(10):429–434

    Article  CAS  PubMed  Google Scholar 

  28. Chen JP, Lo Y, Yu CJ, Hsu C, Shih JY, Yang CH (2008) Predictors of toxicity of weekly docetaxel in chemotherapy-treated non-small cell lung cancers. Lung Cancer 60(1):92–97. doi:10.1016/j.lungcan.2007.09.004

    Article  CAS  PubMed  Google Scholar 

  29. Tsao TC, Chen CH, Chang JW, Lee CH (2006) Weekly short infusion of taxotere at a 4 week cycle in Chinese patients with advanced NSCLC who have failed or relapsed after the frontline platinum-based non-taxane chemotherapy–a Phase II trial. Jpn J Clin Oncol 36(2):80–84. doi:10.1093/jjco/hyi230

    Article  PubMed  Google Scholar 

  30. Li R, Sun L, Wang J, Qian J, Wang Z, Jiao X (2012) Pemetrexed versus docetaxel in second line non-small-cell lung cancer: results and subsets analyses of a multi-center, randomized, exploratory trial in Chinese patients. Pulm Pharmacol Ther 25(5):364–370. doi:10.1016/j.pupt.2012.06.008

    Article  PubMed  Google Scholar 

  31. Sun Y, Wu YL, Zhou CC, Zhang L, Zhang L, Liu XY, Yu SY, Jiang GL, Li K, Qin SK, Ma SL, Han L, Quinlivan M, Orlando M, Zhang XQ (2013) Second-line pemetrexed versus docetaxel in Chinese patients with locally advanced or metastatic non-small cell lung cancer: a randomized, open-label study. Lung Cancer 79(2):143–150. doi:10.1016/j.lungcan.2012.10.015

    Article  CAS  PubMed  Google Scholar 

  32. Sirisinha T, Sirilertrakul S, Jirajarus M, Ratanatharathorn V (2005) Doxetaxel in previously treated non-small cell lung cancer patients: clinical efficacy and quality of life. Southeast Asian J Trop Med Public Health 36(1):246–253

    CAS  PubMed  Google Scholar 

  33. Segawa Y, Kiura K, Hotta K, Takigawa N, Tabata M, Matsuo K, Yoshioka H, Hayashi H, Kawai H, Aoe K, Maeda T, Ueoka H, Tanimoto M (2010) A randomized phase II study of a combination of docetaxel and S-1 versus docetaxel monotherapy in patients with non-small cell lung cancer previously treated with platinum-based chemotherapy: results of Okayama Lung Cancer Study Group (OLCSG) Trial 0503. J Thorac Oncol 5(9):1430–1434. doi:10.1097/JTO.0b013e3181e3248e

    Article  PubMed  Google Scholar 

  34. Kenmotsu H, Tanigawara Y (2015) Pharmacokinetics, dynamics and toxicity of docetaxel: Why the Japanese dose differs from the Western dose. Cancer Sci 106(5):497–504. doi:10.1111/cas.12647

    Article  PubMed Central  CAS  PubMed  Google Scholar 

  35. Pallis AG, Karampeazis A, Vamvakas L, Vardakis N, Kotsakis A, Bozionelou V, Kalykaki A, Hatzidaki D, Mavroudis D, Georgoulias V (2011) Efficacy and treatment tolerance in older patients with NSCLC: a meta-analysis of five phase III randomized trials conducted by the Hellenic Oncology Research Group. Ann Oncol 22(11):2448–2455. doi:10.1093/annonc/mdq772

    Article  CAS  PubMed  Google Scholar 

  36. Claret L, Bruno R, Lu JF, Sun YN, Hsu CP (2014) Exploratory modeling and simulation to support development of motesanib in Asian patients with non-small cell lung cancer based on MONET1 study results. Clin Pharmacol Ther 95(4):446–451. doi:10.1038/clpt.2014.11

    Article  CAS  PubMed  Google Scholar 

  37. Ardizzoia A, Acquati M, Fagnani D, Giordano M, Visini M, Scanni A, Quattrone A, Fusco O, Vergani C, Casartelli C, Tagliabue P, Malugani F, Group P (2004) Second line therapy with weekly low-dose docetaxel for pretreated non-small-cell lung carcinoma patients: a multicenter Italian phase II study. Lung 182(1):1–8. doi:10.1007/s00408-003-1039-5

    Article  CAS  PubMed  Google Scholar 

Download references

Acknowledgments

We wish to acknowledge Angelica Quartino, Ph.D., for helpful discussion regarding analysis of longitudinal neutrophil count data following docetaxel administration.

Author contributions

MS, MG, EC, and JJ wrote the manuscript. MS, MG, NZ, and RW analyzed the data.

Author information

Authors and Affiliations

  1. Department of Clinical Pharmacology, Genentech, Inc., 1 DNA Way, South San Francisco, CA, 94080, USA

    Mark Stroh & Jin Jin

  2. Drug Development Consulting Services, Quantitative Solutions, Menlo Park, CA, USA

    Michelle Green, Nancy Zhang & Russ Wada

  3. Clinical Science, Genentech, Inc., South San Francisco, CA, USA

    Edward Cha

Authors
  1. Mark Stroh
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Michelle Green
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Edward Cha
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Nancy Zhang
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Russ Wada
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Jin Jin
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Mark Stroh.

Ethics declarations

Conflict of interest

The study was funded by F. Hoffmann-La Roche Ltd., Basel, Switzerland, and Genentech, Inc., a member of the Roche Group, South San Francisco, CA, USA. MS, EC, and JJ are Genentech employees and own Roche stock. MG, NZ, and RW are Quantitative Solutions employees.

Electronic supplementary material

Below is the link to the electronic supplementary material.

Flow diagram for NSCLC clinical database search results (PDF 18 kb)

Estimated reference survival curve for patients with a prognostic score (PS) of 0 (PDF 22 kb)

280_2015_2957_MOESM3_ESM.pdf

Survival curves observed (from Di Maio [18]) and predicted by the Di Maio reference model. The black solid lines connect the observed points. The colored (dashed or solid) lines are predictions from the reference model (PDF 103 kb)

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Stroh, M., Green, M., Cha, E. et al. Meta-analysis of published efficacy and safety data for docetaxel in second-line treatment of patients with advanced non-small-cell lung cancer. Cancer Chemother Pharmacol 77, 485–494 (2016). https://doi.org/10.1007/s00280-015-2957-7

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00280-015-2957-7

Keywords

Search

Navigation