Advanced NSCLC: from cytotoxic systemic chemotherapy to molecularly targeted therapy

References

• Anonymous. Chemotherapy in non-small cell lung cancer: a meta-analysis using updated data on individual patients from 52 randomized clinical trials. Non-Small Cell Lung Cancer Collaborative Group. BMJ311,899–909 (1995).
   Google Scholar
• Cullen M, Billingham J, Woodroffe CM et al. Mitomycin, ifosfamide, and cisplatin in unresectable non-small cell lung cancer: effects on survival and quality of life. j Clin. Oncol. 17,3188–3194 (1999).
   PubMed Web of Science ®Google Scholar
• Ellis PA, Smith 1E, Hardy JR et al. Symptom relief with MVP (mitomycin C, vinblastine and cisplatin) chemotherapy in advanced non-small-cell lung cancer. BE Cancer 71,366–370 (1995).
   Google Scholar
• Gatzemeier U, Shepherd FA, Le Chevalier T et al. Activity of gemcitabine in patients with non-small cell lung cancer: a multicentre, extended phase II study. Eur. Cancer32A, 243–248 (1996).
   Google Scholar
• Gridelli C, Perrone F, Gallo C et al Vinorelbine is well-tolerated and active in the treatment of elderly patients with advanced non-small cell lung cancer. A two-stage Phase II study. Eur j Cancer33, 392–397 (1997).
   PubMed Web of Science ®Google Scholar
• Bonomi P, Kim K, Fairclough D et al Comparison of survival and quality of life in advanced non-small cell lung cancer patients treated with two dose levels of paclitaxel combined with cisplatin versus etoposide with cisplatin: results of an Eastern Cooperative Oncology Group trial. Clin. Oncol. 18,623–631 (2000).
   Web of Science ®Google Scholar
• Giaccone G, Splinter TA, Debruyne C et al. Randomized study of paclitaxel-cisplatin versus cisplatin-teniposide in patients with advanced non-small cell lung cancer. The European Organization for Research and Treatment of Cancer Lung Cancer Cooperative Group. j Clin. Oncol. 16, 2133–2141 (1998).
   Google Scholar
• Rudd R, Gower N, James L. Phase III randomised comparison of gemcitabine and carboplatin (GC) with mitomycin, ifosfamide and cisplatin (MIP) in advanced non-small cell lung cancer (NSCLC). Proc. Am. Soc. Gila. Oncol 21 (2002).
   Google Scholar
• Kubota K, Watanabe K, Kunitoh H. Final results of a randomized phase III trial of docetaxel and cisplatin versus vindesine and cisplatin in Stage IV non-small cell lung cancer (NSCLC). Proc. Am Soc. Gun. Oncol 21(2002) (Abstract 1180).
   Google Scholar
• Wozniak AJ, Crowley JJ, Balcerzak SP et al. Randomized trial comparing cisplatin with cisplatin plus vinorelbine in the treatment of advanced non-small cell lung cancer: a Southwest Oncology Group study. J. Gun. Oncol 16, 2459–2465 (1998).
   Google Scholar
• Sandler A, Nemunaitis J, Denham C et al. Phase III trial of gemcitabine plus cisplatin versus cisplatin alone in patients with locally advanced or metastatic non—small cell lung cancer. Jan. Oncol 18, 122–130 (2000).
   Google Scholar
• Schiller JH, Harrington D, Belani Cp et al. Comparison of four chemotherapy regimens for advanced non-small cell lung cancer. N. Engl. Med. 346, 92–98 (2002).
   PubMed Web of Science ®Google Scholar
• ••One of the largest randomized cooperative 22 group trials comparing third-generation cytotoxic regimens.
   Google Scholar
• Kelly K, Crowley J, Bunn PA et al. 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. Gun. Oncol 19, 3210–3218 (2001).
   Google Scholar
• Rodriguez J, Pawel J, Pluzanska A. A multicenter, randomized Phase III study of docetaxel + cisplatin (DC) and docetaxel + carboplatin (DCB) versus vinorelbine + cisplatin (VC) in chemotherapy-naive patients with advanced and metastatic non-small cell lung cancer. Proc. Am. Soc. Gun. Oncol 20, 314a (2001).
   Google Scholar
• Scagliotti G, De Marinis F, Rinaldi M. Phase III randomized trial comparing three platinum-based doublets in advanced non-small cell lung cancer. Proc. Am. Soc. Gun. Oncol 20, 308a (2001).
   Google Scholar
• Van Meerbeeck J, Smit E, Lianes P. A EORTC randomized Phase III trial of three chemotherapy regimens in advanced non-small cell lung cancer (NSCLC). Proc. Am. Soc. Clin. Oncol 20, 308a (2001).
   Google Scholar
• Smith I, O'Brien M, Talbot D. Duration of chemotherapy in advanced non-small celllung cancer: a randomized trial of 3 vs. 6courses of mitomycin, vinblastine, cisplatin.Gun. Oncol 19, 1336–1343 (2001).
   Google Scholar
• Socinski MA, Schell MJ, Peterman A et al Phase III trial comparing a defined duration of therapy versus continuous therapy followed by second-line therapy in advanced-Stage IIIB/IV non-small cell lung cancer. J. Gun. °neat. 20, 1335–1343 (2002).
   Google Scholar
• Depierre A, Quoix E, Mercier M. Maintenance chemotherapy in advanced non-small cell lung cancer (NSCLC): a randomized study of vinorelbine (V) versus observation (OB) in patients (Pts) responding to induction therapy (French Cooperative Oncology Group). Proc. Am. Soc. Gun. Oncol 20, 309a (2001).
   Google Scholar
• Kelly K, Mikhaeel-Kamel N, Pan Z, et al. A phase VII trial of paclitaxel, carboplatin, and gemcitabine in untreated patients with advanced non-small cell lung cancer. an. CancerRes. 6, 3474–3479 (2000).
   Google Scholar
• Greco FA, Burris HA 3rd, Hainsworth JD. Gemcitabine, paclitaxel, and carboplatin for advanced non-small cell lung cancer. Oncology14, 31–34 (2000).
   Google Scholar
• Hussein A, Birch R, Waller J. Preliminary results of a randomized study comparing paclitaxel and carboplatin (PC) with or without gemcitabine (G) in newly diagnosed non-small cell lung cancer (NSCLC). Proc Am Sx. Gun. Oncol 19, 504a (2000).
   Google Scholar
• Comella P, Frasci G, Panza N et al Randomized trial comparing cisplatin, gemcitabine, and vinorelbine with either cisplatin and gemcitabine or cisplatin and vinorelbine in advanced non-small cell lung cancer: interim analysis of a Phase III trial of the Southern Italy Cooperative Oncology Group.j Gun. Oncol 18, 1451–1457 (2000).
   Google Scholar
• Comella P Phase III trial of cisplatin/ gemcitabine with or without vinorelbine orpaclitaxel in advanced non-small cell lung cancer. Semin. Oncol 28, 7–10 (2001).
   Google Scholar
• Alberola V, Camps C, Provencia M. Cisplatin/gemcitabine (CG) versus cisplatin/gemcitabine/vinorelbine (CGV) versus sequential doublets of gemcitabine/ vinorelbine followed by ifosfamide/ vinorelbine (GV/IV) in advanced non-small cell lung cancer (NSCLC): results of a Spanish Lung Cancer Group Phase III Trial (GEPC/98-02). Proc. Am. Soc. Clin. Oiled 20, 308a (2001).
   Google Scholar
• Tan EH, Souquet PJ, Pereira JR. Glob 1: final results of a prospective randomized Phase III trial comparing vinorelbine and cisplatin (NP) versus vinorelbine, ifosfamide, and cisplatin (NIP) in metastatic non-small cell lung cancer (NSCLC) patients (pts). Proc. Am. Soc. Clin. Oncol 20, 326a (2001).
   Google Scholar
• Crino L, Scagliotti GV, Ricci S et al Gemcitabine and cisplatin versus mitomycin, ifosfamide, and cisplatin in advanced non-small cell lung cancer: a randomized Phase III study of the Italian Lung Cancer Project. J. Clin. Oncol 17, 3522–3530 (1999).
   PubMed Web of Science ®Google Scholar
• Le Chevalier T, Brisgand D, Douillard J et al. Randomized study of vinorelbine and cisplatin versus vindesine and cisplatin versus vinorelbine alone in advanced non-small-cell lung cancer: results of a European multicenter trial including 612 patients. Clin. Oncol 12, 360–367 (1994).
   Google Scholar
• Lilenbaum R, Herndon J, List M. Single agent versus combination chemotherapy in advanced non-small cell lung cancer: a CALGB randomized trial of efficacy, quality of life, and cost efffectiveness. Proc. Am. Soc. Clinic Oncol 21, la (2002).
   Google Scholar
• ••Randomized trial demonstrating role ofplatin-doublet over single-agent.
   Google Scholar
• Shepherd F, Dancey J, Ramlau R et al. Prospective randomized trial of docetaxel versus best supportive care in patients with non-small cell lung cancer previously treated with platinum-based chemotherapy. J. Clin. Oncol 18, 2095–2103 (2000).
   PubMed Web of Science ®Google Scholar
• •Phase III trial demonstrating improved survival with 75 mg/m2 of docetaxel over supportive care for second-line NSCLC.
   Google Scholar
• Fossella F, Devore R, RN K et al Randomized phase III trial of docetaxel versus vinorelbine or ifosfamide in patients with advanced non-small cell lung cancer previously treated with plantinum-containing chemotherapy regimens. The TAX 320 Non-Small Cell Lung Cancer Study Group. J. Clin. Oncol 18, 2354–2362 (2000).
   Google Scholar
• Rusch V, Klimstra D, Venkatraman E et al Overexpression of the epidermal growth factor receptor and its ligand transforming growth factor-a is frequent in resectable non-small cell lung cancer but does not predict tumor progression. Clin. Cancer Res. 3, 515–522 (1997).
   PubMed Web of Science ®Google Scholar
• Fukuoka M, Yano S, Giaccone G. Final results from a Phase II trial of ZD1839 aressa') for patients with advanced non-small cell lung cancer (IDEAL 1). Proc. Am. Soc. Clin. Oncol 21, 298a (2002).
   Google Scholar
• ••Phase II trial of the EGFR-TKI ZD1839in second or third line NSCLC.
   Google Scholar
• Kris M, Natale R, Herbst R. A Phase II trial of ZD1839 (IressaTm) in advanced non-small cell lung cancer patients who had failed platinum- and docetaxel-based regimens. Roc. Am. Soc. Gun. Oncol 21, 292a (2002).
   Google Scholar
• ••Phase II trial of third-line ZD1839 inNSCLC.
   Google Scholar
• Douillard J, Giaccone G, Horai T Improvement in disease-related symptoms and quality of life in patients advanced non-small cell lung cancer. Proc. Am. Soc. Clin. Oncol 21, 299a (2002).
   Google Scholar
• Natale R, Skarin A, Maddox A. Improvement in symptoms and quality of life for advanced non-small cell lung cancer patients receiving ZD1839 (Iressa) in IDEAL 2. Roc. Am Soc. Clin. Oncol 21, 292a (2002).
   Google Scholar
• ••Symptom improvement and quality of lifein patients receiving ZD1839 third-line.
   Google Scholar
• Perez-Soler R, Chachoua A, Huberman M et al A Phase II trial of the epidermal growth factor receptor (EGFR) tyrosine kinase inihibitor, OSI-774, following platinum-based chemotherapy, in patients (pts) with advanced, EGFR-expressing, non-small cell lung cancer (NSCLC). Roc. Am Soc. Clin. Oncol 20, 310a (2001).
   Google Scholar
• Baselga J, Pfister D, Cooper Met al. Phase I studies of anti-epidermal growth factor receptor chimeric antibody C225 alone and in combination with cisplatin. j Clin. Oncol 18, 904–914 (2000).
   Google Scholar
• Kim E, Mauer A, Fossella F. A Phase II study of Erbitux (I1AC-C225), an epidermal growth factor receptor blocking antibody, in combination with docetaxel in chemotherapy refractory/resistant patients with advanced non-small cell lung cancer. Roc. Am Soc. Clin. Oncol 21, 293a (2002).
   Google Scholar
• Laptalo L, Lara P, Lau D et al. HER-2/neu screening in advanced non-small cell lung cancer (NSCLC): a California cancer consortium trial of trastuzumab and docetaxel. Roc. Am Soc. Clin. Oncol 20, 335a (2001).
   Google Scholar
• Brabender J, Danenberg K, Metzger R et al. Epidermal growth factor receptor and HER2-neu mRNA expression in non-small cell lung cancer is correlated with survival. Clin. Cancer Res. 7, 1850–1855 (2001).
   Google Scholar
• Patel J, Krug L, Crapanzano J. Clinical characteristics and outcomes of patients with advanced non-small cell lung cancer treated with trastuzumab plus either weekly docetaxel or paclitaxel. Proc. Am. Soc. Clin. Oncol 21, 305a (2002).
   Google Scholar
• Langer C, Adak S, Thor A et al Phase II Eastern Cooperative Oncology Group (ECOG) pilot study of paclitaxwl (P), carboplatin (C), and trastuzumab (T) in HER-2/neu (+) advanced non-small cell lung cancer (NSCLC): early analysis of E2598 Roc. Am. Soc. Clin. Oncol 20, 315a (2001).
   Google Scholar
• Zinner R, Glisson B, Pisters K et al Cisplatin and gemcitabine combined with herceptin in patients (Pts) with HER2 overexpressing, untreated, advanced, non-small cell lung cancer (NSCLC): a Phase II trial. Roc. Am Soc. Clin. Oncol 20, 328a (2001).
   Google Scholar
• Gatzemeier U, Groth G, Hirsh V. Gemcitabine/cisplatin alone and with trastuzumab (Herceptin) in patients with non-small cell lung cancer overexpressing HER2: results of a randomised Phase II study. Proc. Am. Soc. Clin. Oncol 21(2002) (Abstract 1185).
   Google Scholar
• Fontanini G, Vignati S, Boldrini L et al. Vascular endothelial growth factor is associated with neovascularization and influences progression of non-small cell lung carcinoma. Clin. Cancer Res. 3, 861–865 (1997).
   PubMed Web of Science ®Google Scholar
• Han H, Silverman JF, Santucci TS et al. Vascular endothelial growth factor expression in Stage I non-small cell lung cancer correlates with neoangiogenesis and a poor prognosis. Ann. Surg. Oncol 8, 72–79 (2001).
   PubMed Web of Science ®Google Scholar
• Yuan A, Yu CJ, Kuo SH et al. Vascular endothelial growth factor 189 mRNA isoform expression specifically correlates with tumor angiogenesis, patient survival, and postoperative relapse in non-small cell lung cancer. j Clin. Oncol 19, 432–441 (2001).
   Google Scholar
• Angeletti CA, Lucchi M, Fontanini G et al. Prognostic significance of tumoral angiogenesis in completely resected late stage lung carcinoma (Stage IIIA-N2). Impact of adjuvant therapies in a subset of patients at high risk of recurrence. Cancer 78, 409–415 (1996).
   Google Scholar
• Fontanini G, Lucchi M, Vignati S et al Angiogenesis as a prognostic indicator of survival in non-small-cell lung carcinoma: a prospective study. j Natl Cancer Inst. 89, 881–886 (1997).
   PubMed Web of Science ®Google Scholar
• DeVore R, Fehrenbacher L, Herbst R et al A randomized Phase II trial comparing RHUMAB VEGF (recombinant humanized monoclonal antibody to vascular endothial cell growth factor) plus carboplatin/paclitaxel (CP) to CP alone in patients with Stage IIIB/IV NSCLC. Floc. Am. Soc. Clin. Oncol 19, 485a (2000).
   Google Scholar
• •Phase 11 study of chemotherapy ± HuMAb VEGF suggesting prolonged survival.
   Google Scholar
• Johnson D, DeVore r, Kabbinavar F et al Carboplatin (C) + paclitaxel (T) + RhuMab-VEGF (AVF) may prolong survival in advanced non-squamous lung cancer Roc. Am. Soc. Clin. Onto]. 20 (2001).
   Google Scholar
• Fong TA, Shawver LK, Sun L et al 5U5416 is a potent and selective inhibitor of the vascular endothelial growth factor receptor (F1k-1/ KDR) that inhibits tyrosine kinase catalysis, tumor vascularization, and growth of multiple tumor types. Cancer Res. 59, 99–106 (1999).
   PubMed Web of Science ®Google Scholar
• Mendel DB, Laird AD, Smolich BD et al. Development of 5U5416, a selective small molecule inhibitor of VEGF receptor tyrosine kinase activity, as an anti-angiogenesis agent. Anticancer Drug-Design 15, 29–41 (2000).
   PubMedGoogle Scholar
• D'Amato RJ, Loughnan MS, Flynn E et al Thalidomide is an inhibitor of angiogenesis. Proc. Nat/Acad. Sc1 USA 91, 4082–4085 (1994).
   Google Scholar
• Kenyon BM, Browne F, D'Amato RJ. Effects of thalidomide and related metabolites in a mouse corneal model of neovascularization. Experimental Eye Res. 64, 971–978 (1997).
   Google Scholar
• Singhal S, Mehta J, Desikan R et al Antitumor activity of thalidomide in refractory multiple myeloma. N Engl. Merl 341, 1565–1571 (1999).
   PubMed Web of Science ®Google Scholar
• O'Reilly MS, Boehm T, Shing Y et al Endostatin: an endogenous inhibitor of angiogenesis and tumor growth. Ce1188, 277–285 (1997).
   Google Scholar
• •Preclinical study showing prolonged tumor control and occasional cures in preclinical modes with endostatin.
   Google Scholar
• Boehm T, Folkman J, Browder T et al Antiangiogenic therapy of experimental cancer does not induce acquired drug resistance. Nature 390, 404–407 (1997).
   PubMed Web of Science ®Google Scholar
• Herbst R, Tran H, Mullani N et al Phase I clinical trial of recombinant human endostatin (rHE) in patients (Pts) with solid tumors: pharmacokinetic (PK), safety and efficacy analysis using surrogate endpoints of tissue and radiologic response Roc. Am Sx. Clin. Oncol 71a (2001).
   Google Scholar
• Eder J, Clark J, Supko J et al A Phase I pharmacokinetic and pharmacodynamic trial of recombinant human endostatin. Proc. Am. Soc. Clin. Oncol (2001).
   Google Scholar
• Thomas J, Schiller J, Lee F et al. A Phase I pharmacokinetic and pharmacodynamic study of recombinant human endostatin. Proc. Am. Soc. Clin. Oncol (2001).
   Google Scholar
• Schiller J, Hammond L, Carbone D et al Phase 2A trial of squalamine for treatment of advanced non-small cell lung cancer. Proc. Am. Soc. Clin. Oncol 20, 339a (2001).
   Google Scholar
• Smylie M, Mercier R, Aboulafia D et al Phase III study of the matrix met alloprotease (MMP) inhibitor prinomastat in patients having advanced non-small cell lung cancer (NSCLC). Proc. Am. Soc. Clin. awl (2001).
   Google Scholar
• Bissett D, O'Byrne K, von Pawel J. Phase III study of the matrix met alloprotease (MIVIP) inhibitor prinomastat (P) in combination with gemcitabine (G) and cisplatin (C) in non-small cell lung cancer (NSCLC). PrOC. A117. Soc. Clin. Oncol 21 (2002) (Abstract 1183).
   Google Scholar
• Shepherd F, Giaccone G, Debruyne C et al Randomized Double-blind placebo controlled trial of marimastat in patients with small cell lung cancer (SCLC) following response to first-line chemotherapy: an NCIC-CTG and EORTC study. Mr. Am Soc. Clin. Oncol (2001).
   Google Scholar
• Adjei AA, Mauer A, Marks R A Phase II study of the farnesyltransferase inhibitor R115777 in patients with advanced non-small cell lung cancer. Proc. Am. Soc. Clin. Oncol 21, 290a (2002).
   Google Scholar
• Quinlan DC, Davidson AG, Summers CL et al. Accumulation of p53 protein correlates with a poor prognosis in human lung cancer. Cancer Res. 52, 4828–4831 (1992).
   PubMed Web of Science ®Google Scholar
• Isobe T, Hiyama K, Yoshida Y et al. Prognostic significance of p53 and ras gene abnormalities in lung adenocarcinoma patients with Stage I disease after curative resection. JpnJ Cancer Res. 85, 1240–1246 (1994).
   Google Scholar
• Roth JA, Grammer SF, Swisher SG et al Gene therapy approaches for the management of non-small cell lung cancer. Semin. Oncol 28, 50–56 (2001).
   PubMedGoogle Scholar
• ••Excellent review article on gene therapy.
   Google Scholar
• Roth JA, Nguyen D, Lawrence DD et al Retrovirus-mediated wild-type p53 gene transfer to tumors of patients with lung cancer. Natum Med. 2, 985–991 (1996).
   PubMed Web of Science ®Google Scholar
• Swisher SG, Roth JA, Nemunaitis J et al Adenovirus-mediated p53 gene transfer in advanced non-small cell lung cancer. j Natl Cancer Inst. 91, 763–771 (1999).
   PubMed Web of Science ®Google Scholar
• Schuler M, Herrmann R, De Greve JL et al Adenovirus-mediated wild-type p53 gene transfer in patients receiving chemotherapy for advanced non-small cell lung cancer: results of a multicenter Phase II study. Clin. Oncol 19, 1750–1758 (2001).
   Google Scholar
• Kubba S, Adak S, Schiller J. Phase I trial of adenovirus p53 in bronchioloalveolar cell lung carcinoma (BAC) administered by bronchoalveolar lavage. Proc. Am Soc. Clin. Oncol 19 (2000).
   Google Scholar
• Yuen A, Halsey J, Fisher G. Phase VII trial of ISIS 3521, an antisense inhibitor of PKC- a, with carboplatin and paclitaxel in non-small cell lung cancer. Proc. Am. Soc. Clin. Oncol 20 (2001).
   Google Scholar
• •Phasetrial of antisense mRNA toPKC-a showing promising activity when combined with chemotherapy.
   Google Scholar
• Ritch PS, Belt R, George S. Phase VII trial of ISIS 3521/LY900003, an antisense inhibitor of PKC-a with cisplatin and gemcitabine in advanced non-small cell lung cancer. Proc. Am. Soc. Clin. Oncol 21, 309a (2002).
   Google Scholar
• Moore MR, Saleh M, Jones CM. Phase II trial of ISIS 3521/LY900003, an antisense inhibitor of PKC-a, with docetaxel in non-small cell lung cancer Proc. Am. Soc. Clin. Oncol 21, 297a (2002).
   Google Scholar
• Soslow RA, Dannenberg AJ, Rush D et al COX-2 is expressed in human pulmonary, colonic, and mammary tumors. Cancer 89, 2637–2645 (2000).
   PubMed Web of Science ®Google Scholar
• Hida T, Yatabe Y, Achiwa H et al Increased expression of cyclooxygenase 2 occurs frequently in human lung cancers, specifically in adenocarcinomas. Cancer Res. 58, 3761–3764 (1998).
   PubMed Web of Science ®Google Scholar
• Wolff H, Saukkonen K, Anttila S et al Expression of cyclooxygenase-2 in human lung carcinoma. Cancer Res. 58, 4997–5001 (1998).
   PubMed Web of Science ®Google Scholar
• Brabender J, Park J, Metzger R et al Prognostic significance of cyclooxygenase 2 mRNA expression in non-small cell lung cancer. Ann. Surg. 235, 440–443 (2002).
   Google Scholar
• Khuri F, Wu H, Lee J et al Cyclooxygenase- 2 overexpression is a marker of poor prognosis in Stage I non-small cell lung cancer. Clin. Cancer Res. 7, 861–867 (2001).
   Google Scholar
• Hida T, Kozaki K, Muramatsu H et al. Cyclooxygenase-2 inhibitor induces apoptosis and enhances cytotoxicity of various anticancer agents in non-small cell lung cancer cell lines. Clin. Cancer Res. 6, 2006–2011 (2000).
   Google Scholar
• •Preclinical study demonstrating antitumor activity of COX-2 inhibitors with chemotherapy.
   Google Scholar
• Altorki NK, S KR, Port JL. Celecoxib (Celebrex), a selective COX-2 inhibitor, enhances the response to preoperative paclitaxelicarboplatin in early stage non-small cell lung cancer. Pmc. Am. Soc. Clin. Oncol 21, 26a (2002).
   Google Scholar
• Csiki I, Dang T, Gonzalez A. Cyclooxygenase-2 inhibition + docetaxel in recurrent non-small cell lung cancer, preliminary results of a phase II trial (TH0-0054). Proc. Am. Soc. Clin. Oncol 21, 297a (2002).
   Google Scholar