PMID- 21969509 OWN - NLM STAT- MEDLINE DCOM- 20111220 LR - 20171116 IS - 1527-7755 (Electronic) IS - 0732-183X (Linking) VI - 29 IP - 31 DP - 2011 Nov 1 TI - Randomized, double-blind, placebo-controlled phase II study of single-agent oral talactoferrin in patients with locally advanced or metastatic non-small-cell lung cancer that progressed after chemotherapy. PG - 4129-36 LID - 10.1200/JCO.2010.34.4127 [doi] AB - PURPOSE: To investigate the activity and safety of oral talactoferrin (TLF) in patients with stages IIIB to IV non-small-cell lung cancer (NSCLC) for whom one or two prior lines of systemic anticancer therapy had failed. PATIENTS AND METHODS: Patients (n = 100) were randomly assigned to receive either oral TLF (1.5 g in 15 mL phosphate-based buffer) or placebo (15 mL phosphate-based buffer) twice per day in addition to supportive care. Oral TLF or placebo was administered for a maximum of three 14-week cycles with dosing for 12 consecutive weeks followed by 2 weeks off. The primary objective was overall survival (OS) in the intent-to-treat (ITT) patient population. Secondary objectives included progression-free survival (PFS), disease control rate (DCR), and safety. RESULTS: TLF was associated with improvement in OS in the ITT patient population, meeting the protocol-specified level of significance of a one-tailed P = .05. Compared with the placebo group, median OS increased by 65% in the TLF group (3.7 to 6.1 months; hazard ratio, 0.68; 90% CI, 0.47 to 0.98; P = .04 with one-tailed log-rank test). Supportive trends were also observed for PFS and DCR. TLF was well tolerated and, generally, there were fewer adverse events (AEs) and grade >/= 3 AEs reported in the TLF arm. AEs were consistent with those expected in late-stage NSCLC. CONCLUSION: TLF demonstrated an apparent improvement in OS in patients with stages IIIB to IV NSCLC for whom one or two prior lines of systemic anticancer therapy had failed and was well tolerated. These results should be confirmed in a global phase III trial. FAU - Parikh, Purvish M AU - Parikh PM AD - Tata Memorial Hospital, Mumbai, India. FAU - Vaid, Ashok AU - Vaid A FAU - Advani, Suresh H AU - Advani SH FAU - Digumarti, Raghunadharao AU - Digumarti R FAU - Madhavan, Jayaprakash AU - Madhavan J FAU - Nag, Shona AU - Nag S FAU - Bapna, Ajay AU - Bapna A FAU - Sekhon, Jagdev S AU - Sekhon JS FAU - Patil, Shekhar AU - Patil S FAU - Ismail, Preeti M AU - Ismail PM FAU - Wang, Yenyun AU - Wang Y FAU - Varadhachary, Atul AU - Varadhachary A FAU - Zhu, Junming AU - Zhu J FAU - Malik, Rajesh AU - Malik R LA - eng PT - Clinical Trial, Phase II PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20111003 PL - United States TA - J Clin Oncol JT - Journal of clinical oncology : official journal of the American Society of Clinical Oncology JID - 8309333 RN - 0 (Antineoplastic Agents) RN - 0 (Platinum Compounds) RN - 7A055A9QRR (talactoferrin alfa) RN - EC 3.4.21.- (Lactoferrin) SB - IM MH - Administration, Oral MH - Antineoplastic Agents/administration & dosage/*therapeutic use MH - Antineoplastic Combined Chemotherapy Protocols/therapeutic use MH - Carcinoma, Non-Small-Cell Lung/*drug therapy/secondary MH - Disease Progression MH - Double-Blind Method MH - Drug Administration Schedule MH - Female MH - Humans MH - Kaplan-Meier Estimate MH - Lactoferrin/administration & dosage/*therapeutic use MH - Lung Neoplasms/*drug therapy/pathology MH - Male MH - Middle Aged MH - Neoplasm Staging MH - Odds Ratio MH - Platinum Compounds/administration & dosage MH - Proportional Hazards Models MH - Treatment Failure MH - Treatment Outcome EDAT- 2011/10/05 06:00 MHDA- 2011/12/21 06:00 CRDT- 2011/10/05 06:00 PHST- 2011/10/05 06:00 [entrez] PHST- 2011/10/05 06:00 [pubmed] PHST- 2011/12/21 06:00 [medline] AID - JCO.2010.34.4127 [pii] AID - 10.1200/JCO.2010.34.4127 [doi] PST - ppublish SO - J Clin Oncol. 2011 Nov 1;29(31):4129-36. doi: 10.1200/JCO.2010.34.4127. Epub 2011 Oct 3.