Skip to main content

Advertisement

SpringerLink
Log in

A phase II trial of weekly chemotherapy with paclitaxel plus gemcitabine as a first-line treatment in advanced non-small-cell lung cancer

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

Abstract

Purpose

The efficacy and toxicity of combined paclitaxel (PTX) and gemcitabine (GEM) was evaluated as a protocol for first-line chemotherapy in 40 patients with advanced non-small-cell lung cancer (NSCLC).

Methods

Paclitaxel, 100 mg/m2, was administered intravenously (IV) as a 1-h infusion, followed by GEM, 1,000 mg/m2, IV over 30 min on days 1 and 8 of a 21-day cycle. The median age of patients was 66 years with a range of 33–75 years. Nearly all patients (39/40) had an ECOG performance status of 0 or 1. Thirteen patients (32%) had initial stage IIIB disease and 27 patients (68%) had stage IV disease. Histological subtypes were adenocarcinoma (73%) and squamous cell carcinoma (25%).

Results

Twenty-two patients (55%) achieved a partial response and none achieved a complete response, giving an overall response rate of 55% (95% confidence interval: 38.2–71.8%). Disease stability was achieved in 14 patients (35%), and 4 patients (10%) had progressive disease. The median survival time was 11.9 months (95% CI: 10.3–14 months), with a 1-year survival rate of 47.5%. Grade 3 or 4 hematological toxicities observed included neutropenia in 37.5%, anemia in 2.5%, and thrombocytopenia in 5.0% of these patients. Non-hematologic toxicities were mild, with the exception of grade 3 and 4 pneumonitis. There were no deaths due to toxicity.

Conclusion

Weekly chemotherapy with PTX plus GEM is effective and is acceptable for the first line treatment of advanced NSCLC.

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

Similar content being viewed by others

References

  1. Akerley W 3rd (2000) Paclitaxel in advanced non-small cell lung cancer: an alternative high-dose weekly schedule. Chest 117(4 Suppl 1):152S–155S

    Article  PubMed  CAS  Google Scholar 

  2. Akerley W, Rathore R, Ready N, Leone L, Sikov W, Safran H et al (2002) A phase I study of a weekly schedule of paclitaxel and carboplatin in patients with advanced carcinoma. Cancer 95:2000–2005

    Article  PubMed  CAS  Google Scholar 

  3. Akerley W, Safran H, Zaner K, Ready N, Mega T, Kennedy T (2006) Phase II trial of weekly paclitaxel and gemcitabine for previously untreated, stage IIIB-IV nonsmall cell lung cancer. Cancer 107:1050–1054

    Article  PubMed  CAS  Google Scholar 

  4. Anderson H, Lund B, Bach F, Thatcher N, Walling J, Hansen HH (1994) Single-agent activity of weekly gemcitabine in advanced non-small cell lung cancer: a phase II study. J Clin Oncol 12:1821–1826

    PubMed  CAS  Google Scholar 

  5. Ando M, Wakai K, Seki N, Tamakoshi A, Suzuki K, Ito Y et al (2003) Attributable and absolute risk of lung cancer death by smoking status: findings from the Japan collaborative cohort study. Int J Cancer 105:249–254

    Article  PubMed  CAS  Google Scholar 

  6. Belani CP, Dakhil S, Waterhouse DM, Desch CE, Rooney DK, Clark RH et al (2007) Randomized phase II trial of gemcitabine plus weekly versus three-weekly paclitaxel in previously untreated advanced non-small cell lung cancer. Ann Oncol 18:110–115

    Article  PubMed  CAS  Google Scholar 

  7. Bhatia S, Hanna N, Ansari R, Pletcher W, Einhorn L, Sandler A et al (2002) A Phase II study of weekly gemcitabine and paclitaxel in patients with previously untreated stage IIIb and IV non-small cell lung cancer. Lung Cancer 38:73–77

    Article  PubMed  Google Scholar 

  8. Bonomi P, Kim K, Kusler J, Johnson D (1997) Cisplatin/etoposide vs paclitaxel/cisplatin/G-CSF vs paclitaxel/cisplatin in non-small-cell lung cancer. Oncology (Williston Park) 4(Suppl 3):9–10

    Google Scholar 

  9. Buccheri G, Ferrigno D (2004) Cuneo lung cancer study group. Second-line weekly paclitaxel in patients with inoperable non-small cell lung cancer who fail combination chemotherapy with cisplatin. Lung Cancer 45:227–236

    Article  PubMed  Google Scholar 

  10. Chang AY, Rubins J, Asbury R, Boros L, Hui LF (2001) Weekly paclitaxel in advanced non-small cell lung cancer. Semin Oncol 28(4 Suppl 14):10–13

    Article  PubMed  CAS  Google Scholar 

  11. Crowley J, Furuse K, Kawahara M, Fukushima M, Kawaguchi T, Williamson S et al (2006) Second Japan-SWOG common arm analysis of paclitaxel/carboplatin in advanced stage non-small cell lung cancer (NSCLC): a model for testing population-related pharmacogenomics (#7050). Proc Am Soc Clin Oncol 24:376S

    Google Scholar 

  12. De Pas T, Putzu C, Curigliano G, Noberasco C, Sabrina B, Catania C et al (2006) A proper schedule of weekly paclitaxel and gemcitabine combination is highly active and very well tolerated in NSCLC patients. Lung Cancer 54:359–364

    Article  PubMed  Google Scholar 

  13. Georgoulias V, Papadakis E, Alexopoulos A, Tsiafaki X, Rapti A, Veslemes M et al (2001) Platinum-based and non-platinum-based chemotherapy in advanced non-small-cell lung cancer: a randomized multicentre trial. Lancet 357:1478–1484

    Article  PubMed  CAS  Google Scholar 

  14. Gillenwater HH, Stinchcombe TE, Qaqish BF, Tyann M, Hensing TA, Socinski MA (2005) A phase II trial of weekly paclitaxel and gemctiabine infused at a constant rate in patients with advanced non-small cell lung cancer. Lung Cancer 47:413–419

    Article  PubMed  Google Scholar 

  15. Gridelli C, Perrone F, Palmeri S, D’Aprile M, Cognetti F, Rossi A et al (1996) Mitomycin C plus vindesine plus etoposide(MEV) versus mitomycin C plus vindesine plus cisplatin(MVP) in stage IV non-small-cell lung cancer: A phase III multicentre randomised trial. The “Gruppo Oncologico Centro-Sud-Isole” (G.O.C.S.I.). Ann Oncol 7:821–826

    PubMed  CAS  Google Scholar 

  16. Juan O, Albert A, Ordono F, Casany R, Caranana V, Campos JM et al (2002) Low-dose weekly paclitaxel as second-line treatment for advanced non-small cell lung cancer: a phase II study. Jpn J Clin Oncol 32:449–454

    Article  PubMed  Google Scholar 

  17. Kelly K, Crowley J, Bunn PA Jr, Presant CA, Grevstad PK, Moinpour CM et al (2001) Randomized phase III trial of paclitaxel plus carboplatin versus vinorelbine plus cisplatin in the treatment of patients with advanced non-small-cell lung cancer: a southwest oncology group trial. J Clin Oncol 19:3210–3218

    PubMed  CAS  Google Scholar 

  18. Kosmidis P, Mylonakis N, Nicolaides C, Kalophonos C, Samantas E, Boukovinas J et al (2002) Paclitaxel plus carboplatin versus gemcitabine plus paclitaxel in advanced non-small-cell lung cancer: a phase III randomized trial. J Clin Oncol 20:3578–3585

    Article  PubMed  CAS  Google Scholar 

  19. Kosmidis PA, Kalofonos HP, Christodoulou C, Syrigos K, Makatsoris T, Skarlos D et al (2008) Paclitaxel and gemcitabine versus carboplatin and gemcitabine in patients with advanced non-small-cell lung cancer. A phase III study of the Hellenic cooperative oncology group. Ann Oncol 19:115–122

    Article  PubMed  CAS  Google Scholar 

  20. Mori K, Kamiyama Y, Kondo T, Kano Y, Kodama T (2007) Phase II study of weekly chemotherapy with paclitaxel and gemcitabine as second-line treatment for advanced non-small cell lung cancer after treatment with platinum-based chemotherapy. Cancer Chemother Pharmacol 60:189–195

    Article  PubMed  CAS  Google Scholar 

  21. Peto R, Chen ZM, Boreham J (1999) Tobacco—the growing epidemic. Nat Med 5:15–17

    Article  PubMed  CAS  Google Scholar 

  22. Recchia F, Saggio G, Cesta A, Candeloro G, Rea S (2005) Paclitaxel plus gemcitabine in advanced non-small cell lung cancer patients with low performance status. Anticancer Res 25:409–414

    PubMed  CAS  Google Scholar 

  23. Scagliotti GV, De Marinis F, Rinaldi M, Crino L, Gridelli C, Ricci S et al (2002) Italian lung cancer project. Phase III randomized trial comparing three platinum-based doublets in advanced non-small-cell lung cancer. J Clin Oncol 20:4285–4291

    Article  PubMed  CAS  Google Scholar 

  24. Schiller JH, Harrington D, Belani CP, Langer C, Sander A, Krook J et al (2002) Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer. N Engl J Med 346:92–98

    Article  PubMed  CAS  Google Scholar 

  25. Sekine I, Nishiwaki Y, Watanabe K, Yoneda S, Saijo N (1996) Phase II study of 3-hour infusion of paclitaxel in previously untreated non-small cell lung cancer. Clin Cancer Res 2:941–945

    PubMed  CAS  Google Scholar 

  26. Socinski MA, Schell MJ, Bakri K, Peterman A, Lee JH, Unger P et al (2002) Second-line, low-dose, weekly paclitaxel in patients with stage IIIB/IV nonsmall cell lung carcinoma who fail first-line chemotherapy with carboplatin plus paclitaxel. Cancer 95:1265–1273

    Article  PubMed  CAS  Google Scholar 

  27. ten Bokkel Huinink WW, Bergman B, Chemaissani A, Dornoff W, Drings P, Kellokumpu-Lehtinen PL et al (1999) Single-agent gemcitabine: an active and better tolerated alternative to standard cisplatin-based chemotherapy in locally advanced or metastatic non-small cell lung cancer. Lung Cancer 26:85–94

    Article  PubMed  CAS  Google Scholar 

  28. Treat J, Belani CP, Edelman MJ, Socinski MA, Ansari RH, Obasaju CK et al (2005) A randomized phase III trial of gemcitabine (G) in combination with carboplatin (C) or paclitaxel (P) versus paclitaxel plus carboplatin in advanced (Stage IIIB, IV) non-small cell lung cancer (NSCLC): updata of the Alpha Oncology trial (A1-99002L). (#7025). Proc Am Soc Clin Oncol 23:1096S

    Google Scholar 

  29. Yamamoto N, Fukuoka M, Negoro SI, Nakagawa K, Saito H, Matsui K et al (2004) Randomised phase II study of docetaxel/cisplatin vs docetaxel/irinotecan in advanced non-small-cell lung cancer: a West Japan thoracic oncology group study (WJTOG9803). Br J Cancer 90:87–92

    Article  PubMed  CAS  Google Scholar 

  30. Yasuda K, Igishi T, Kawasaki Y, Kato K, Matsumoto S, Katayama S et al (2004) Phase II study of weekly paclitaxel in patients with non-small cell lung cancer who have failed previous treatments. Oncology 66:347–352

    Article  PubMed  CAS  Google Scholar 

Download references

Acknowledgments

This work was supported in part by a Grant-in-Aid for Cancer Research from the Ministry of Health, Labor and Welfare (Tokyo, Japan), and by the second-term comprehensive 10-year strategy for cancer control.

Conflict of interest statement

None.

Author information

Authors and Affiliations

  1. Division of Thoracic Oncology, Department of Medical Oncology, Tochigi Cancer Center, 4-9-13, Yohnan, Utsunomiya, Tochigi, 320-0834, Japan

    Kiyoshi Mori, Hiroyuki Kobayashi, Yukari Kamiyama, Yasuhiko Kano & Tetsuro Kodama

Authors
  1. Kiyoshi Mori
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Hiroyuki Kobayashi
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Yukari Kamiyama
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Yasuhiko Kano
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Tetsuro Kodama
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Kiyoshi Mori.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Mori, K., Kobayashi, H., Kamiyama, Y. et al. A phase II trial of weekly chemotherapy with paclitaxel plus gemcitabine as a first-line treatment in advanced non-small-cell lung cancer. Cancer Chemother Pharmacol 64, 73–78 (2009). https://doi.org/10.1007/s00280-008-0846-z

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00280-008-0846-z

Keywords

Search

Navigation