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L. Paz-Ares
Moderator of
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E11 - Practical Aspects of Targeted Therapies (ID 11)
- Event: WCLC 2013
- Type: Educational Session
- Track: Medical Oncology
- Presentations: 5
- Moderators:M. Millward, L. Paz-Ares
- Coordinates: 10/30/2013, 14:00 - 15:30, Plenary Hall, Ground Level
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E11.1 - Who Should We Test for Genetic Alterations, When and How? (ID 422)
14:00 - 14:20 | Author(s): R. Stahel
- Abstract
Abstract not provided
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E11.2 - Management Options at First Progression of EGFR Mutant Tumours (ID 423)
14:20 - 14:40 | Author(s): K. Park
- Abstract
- Presentation
Abstract
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E11.3 - Panel Discussion: MDT - Managing Toxicities and Evaluating Drug Interactions (ID 424)
14:40 - 14:55 | Author(s): P. Yang
- Abstract
- Presentation
Abstract
Managing Toxicities of Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors in Non-small-cell Lung Cancer Treatment: Focus on Skin and Liver Toxicities Pan-Chyr Yang MD, PhD. Department of Internal Medicine, National Taiwan University College of Medicine, Taipei, Taiwan. Several recent prospective randomized controlled studies have confirmed the efficacy of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs), including Gefitinib, Erlotinib and Afatinib, in the treatment of non-small-cell lung cancer (NSCLC) harboring EGFR activating mutations (such as L858R or deletions in exon 19). Due to less systematic toxicity, treatment with EGFR TKIs is better tolerated, compared to platinum-based chemotherapy. However, signaling pathways downstream to EGFR are also important to the integrity and function of normal epithelium, and specific adverse effects thus can develop during EGFR TKI treatment. Acneiform rash and diarrhea are the most common adverse effects reported in the clinical trials. Although most adverse effects of EGFR TKIs can be well managed without treatment discontinuation, some uncommon adverse effects, such as hepatotoxicity and interstitial pneumonitis, can be serious and life threatening. Therefore, cautious monitoring for adverse effects is important to NSCLC patients receiving EGFR TKI treatment. Management of Skin Toxicity Various cutaneous adverse effects can occur during EGFR TKI treatment, including acneiform rash, dry skin (xerosis), pruritus, nail or periungual alternations, and hair changes. Acneiform rash usually involves the upper torso, and appears within 2 weeks of treatment initiation. Topical steroids (such as 2.5% hydrocortisone acetate cream), tacrolimus, or antibiotics (such as clindamycin 1% to 2%) are effective treatments for patients with mild acneiform rash. Oral doxycycline (100 mg twice daily) or minocycline (100 mg twice daily) can be used for those with moderate to severe eruptions. When purulent discharge or painful eruptions occurs, secondary infection should be suspected. Broad-spectrum empirical antibiotics are recommended for initial treatment of bacterial super-infection, and appropriate skin swab for culture is required for identification of the causative bacteria. For patients with pruritus during treatment with EGFR TKIs, topical steroid with moderate strength or anti-pruritics (such as 5% doxepin cream) can be used for symptomatic relief. Oral antihistamines may be required for those with more severe symptoms. Topical moisturizing cream or ointment and 12% ammonium lactate cream can help relieving xerosis associated with EGFR TKI treatment. For patients with paronychia associated with EGFR TKI treatment, topical antibiotics and ultrapotent steroids are recommended, and topical silver nitrate application can be used for more severe cases. Although cutaneous toxicities are frequent during EGFR TKI treatment, most of these cutaneous toxicities are mild to moderate in severity, and can be adequately treated without dose reduction or treatment discontinuation. Management of Liver Toxicity Hepatoxicity associated with EGFR TKIs is less commonly reported in clinical trials. However, recent two phase III Japanese clinical trials reported that severe hepatotoxicity (defined as serum hepatic aminotrasferase levels above five times the upper limit of normal) developed in 16% to 28% of patients receiving gefitinib treatment. Furthermore, patients with lethal hepatotoxicity associated with Erlotinib treatment were also reported. Therefore, it is important to regularly monitor serum levels of hepatic aminotransferases in NSCLC patients receiving EGFR TKI treatment. Once severe hepatitis develops during EGFR TKI treatment, timely discontinuation of EGFR TKIs is required, with thorough evaluation of other potential etiologies, such as acute viral hepatitis. It is not recommended to re-challenge the patients with the same EGFR TKIs, which may induce more severe hepatic damage even after dose reduction. The efficacy of steroids in preventing hepatotoxicity is unknown and is not consistent in different reports. Routine steroid treatment is thus not suggested in patients with hepatotoxicity associated with EGFR TKIs. Successful Erlotinib or Gefitinib treatment has been reported in some patients recovering from severe Gefitinib- or Erlottinib-associated hepatotoxicity, respectively. Since different CYP450 enzymes are involved in the metabolism of different EGFR TKIs, trials of different EGFR TKIs may be considered after recovery from hepatitis, especially in responders to EGFR TKI treatment. References: 1. Hirsh V. Managing treatment-related adverse events associated with egfr tyrosine kinase inhibitors in advanced non-small-cell lung cancer. Curr Oncol 2011;18:126-138. 2. Lacouture ME. Mechanisms of cutaneous toxicities to EGFR inhibitors. Nat Rev Cancer 2006; 6: 803-12. 3. Wang SH, Yang CH, Chiu HC, Hu FC, Chan CC, Liao YH, Chen HC, Chu CY. Skin manifestations of gefitinib and the association with survival of advanced non-small cell lung cancer in Taiwan. Dermatologica Sinica 2011; 29: 13-18. 4. Lacouture ME, Schadendorf D, Chu CY, Uttenreuther-Fischer M, Stammberger U, O’Brien D, Hauschild A. Dermatologic adverse events associated with afatinib: an oral ErbB family blocker. Expert Rev Anticancer Ther 2013; 13: 721-8. 5. Navarro VJ, Senior JR. Drug-related hepatotoxicity. N Engl J Med 2006;354:731-739. 6. Takeda M, Okamoto I, Tsurutani J, Oiso N, Kawada A, Nakagawa K. Clinical impact of switching to a second EGFR-TKI after a severe AE related to a first EGFR-TKI in EGFR-mutated NSCLC. Japanese journal of clinical oncology 2012;42:528-533.Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.
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E11.3 - Panel Discussion: MDT - Managing Toxicities and Evaluating Drug Interactions (ID 425)
14:55 - 15:10 | Author(s): K. O'Byrne
- Abstract
- Presentation
Abstract not provided
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E11.3 - Panel Discussion: MDT - Managing Toxicities and Evaluating Drug Interactions (ID 426)
15:10 - 15:25 | Author(s): A. Fraser
- Abstract
- Presentation
Abstract
MANAGING TARGETED THERAPY PATIENTS IN A NURSE LED CLINIC Numbers of lung cancer patients on targeted therapies are growing as testing becomes more widely available and cost effective. Lung cancer Clinical Nurse Specialists and Nurse Practitioners are in an ideal position to manage these patients for a number of reasons. Patients on Targeted Therapies present with unique toxicity profiles which CNS’s and NP’s are developing a growing level of expertise in managing. Toxicity profiles include rash, nausea, fatigue, cachexia, diarrhoea, deranged liver function tests, and shortness of breath. Nurses tend to be the most frequently contacted person between clinic visits, triaging and managing toxicities. They are ideally placed to proactively monitor patients, aiding continuity of care and reducing hospital admissions. Patients report improved communication, education around management, and continuity, with reduced treatment related anxiety, in nurse led clinics. Many CNS and NPs can provide a prescription service adding to continuity of care. Support for nurse led clinics is essential to ensure patient safety and should be run alongside the oncologist’s clinics. Competency of the nurse leading the clinic must be maintained through identified supervisors. Utilisation of evidence based tools help to ensure best practice is maintained.Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.
Author of
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E03 - Chemotherapy for NSCLC (ID 3)
- Event: WCLC 2013
- Type: Educational Session
- Track: Medical Oncology
- Presentations: 1
- Moderators:R. Pirker, J. Bishop
- Coordinates: 10/28/2013, 14:00 - 15:30, Bayside Auditorium A, Level 1
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E03.2 - Selecting Patients for Maintenance Therapy (ID 383)
14:25 - 14:45 | Author(s): L. Paz-Ares
- Abstract
- Presentation
Abstract not provided
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MO11 - Screening and Epidemiology (ID 131)
- Event: WCLC 2013
- Type: Mini Oral Abstract Session
- Track: Imaging, Staging & Screening
- Presentations: 1
- Moderators:P. Zimmerman, J. Bowden
- Coordinates: 10/28/2013, 16:15 - 17:45, Bayside 201 - 203, Level 2
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MO11.11 - IL-11 and CCL-1: Novel protein diagnostic biomarkers of lung adenocarcinoma in bronchoalveolar lavage (BAL) (ID 2876)
17:15 - 17:20 | Author(s): L. Paz-Ares
- Abstract
- Presentation
Background
Lung cancer (LC) and chronic obstructive pulmonary disease (COPD) are smoking related diseases and the presence of COPD increases itself the risk of developing lung cancer, probably due to underlying inflammation. LC is typically detected at late stages of the disease and carries a dismal prognosis. There is an unmet need for useful early detection methods of lung cancer in high risk subjects, such as smokers.Methods
The expression of inflammatory proteins was studied in bronchoalveolar lavage samples (BAL) by antibody arrays in a prospective discovery cohort of 60 patients with the following inclusion criteria: age > 40 years, diagnostic broncoscopy due to hemoptysis or pulmonary nodule, smokers or ex-smokers pack of more than 30 pack-years, divided into four groups (control, LC, COPD, LC & COPD). Relevant biomarkers were validated by western blot. Additional validation was carried out by ELISA in two independent controlled cohorts of 139 (control, LC, COPD, LC & COPD) and 160 patients (control, all LC histological subtypes).Results
CCL-1 and IL-11 were selectively expressed in samples of adenocarcinoma patients, with or without COPD (p<0•001) in the discovery cohort. These proteins exhibited a remarkable diagnostic performance for lung adenocarcinoma in an independent cohort of 139 patients. ROC curves showed that the optimum diagnostic cutoff value for IL-11 was 42 pg/mL (area under curve [AUC] 0•93 [95% CI 0•896-0•975], sensitivity 90%, specificity 86%), and for CCL-1 was 39•5 pg/ml (0•83 [95% CI 0•749-0•902], sensitivity 83%, specificity 74%). Further validation of the ELISA biomarkers at the mentioned cutoffs was performed in an additional cohort of 160 patients (20 controls, 66 LC, 74 LC & COPD). There was a significant correlation between BAL levels of IL-11 and CCL-1 (r2= 0•76, p<0•001), and the use of both biomarkers increased the diagnostic accuracy to 96,1% in the two validation cohorts. Appropriate diagnostic performance was observed for all subgroups regardless of stage at diagnosis, involvement of bronchial tract, pack-years smoked, and number of cells in BAL.Diagnostic performance of IL-11 and CCL-1 in the first validation cohort (N=139) Adenocarcinoma vs all patients AUC (95%IC) Sensivity (95%IC) Specificity (95%IC) PPV (95%IC) NPV (95%IC) Positive LR Negative LR IL-11 0.93 (0.896-0.975) 90.2% (79%-95.7%) 88.7% (80.6%-93.5%) 80.7% (68.7%-88.9%) 94.5% (87.8%-97.6%) 7.95 (4.53-13.98) 0.11 (0.05-0.26) CCL-1 0.83 (0.749-0.902) 80% (66.4%-87.7%) 74.1% (63.9%-82.2%) 72.1% (59.2%-73.4%) 86.3% (76.6%-92.4%) 3.02 (2.05-4.47) 0.29 (0.17-0.52) IL11 and CCL-1 71.2% (57.7%-81.7%) 94.4% (88.4%-97.4%) 86% (72.7%-93.4%) 87.2% (79.9%-92.1%) 12.8 (5.77-28.41) 0.31 (0.20-0.47) IL-11 and/or CCL-1 94.3% (84.6%-98.1%) 74.1% (65.1%-81.4%) 64.1% (53%-73.9%) 96.4% (89.9%-98.8%) 3.64 (2.63-5.04) 0.08 (0.03-0.23) Diagnostic performance of IL-11 and CCL-1 in the second validation cohort (N=160) Adenocarcinoma vs all patients AUC (95%IC) Sensivity (95%IC) Specificity (95%IC) PPV (95%IC) NPV (95%IC) Positive LR Negative LR IL-11 0.95 (0.92-0.98) 90.6% (79.7%-95.9%9 83% (86.8%-87.7%) 60.8% (49.7%-70.8%) 96.8% (92.7%-98.6%) 5.32 (3.81-7.41) 0.11 (0.05-0.26) CCL-1 0.91 (0.87-0.96) 91.7% (80.4%-96.7%) 77.5% (71.0%-82.9%) 51.2% (40.8%-61.4%) 97.3% (93.3%-99%) 4.08 (3.09-5.04) 0.11 (0.04-0.28) IL11 and CCL-1 71.2% (57.7%-81.7%) 96.3% (92.5%-98.2%) 84.1% (70.6%-92.1%) 92.3% (87.7%-95.3%) 19.1 (9-41.13) 0.3 (0.19-0.46) IL-11 and/or CCL-1 92.3% 82.6%-98.1%) 84% (78%-88.5%) 62.5% (51.5%-72.3%) 98.1% (94.6%-99.4%) 5.88 (4.21-8.22) 0.07 (0.02-0.20) Conclusion
IL-11 and CCL-1 are highly specific biomarkers with great accuracy for the diagnosis of lung adenocarcinoma in BAL specimens. Further study of these proteins as markers for early diagnosis and screening in plasma and other biological materials is warranted.Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.
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O03 - NSCLC - Targeted Therapies I (ID 113)
- Event: WCLC 2013
- Type: Oral Abstract Session
- Track: Medical Oncology
- Presentations: 1
- Moderators:J. Ross, J.C. Yang
- Coordinates: 10/28/2013, 10:30 - 12:00, Bayside Auditorium B, Level 1
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O03.02 - Randomized Phase-3 trial (INSPIRE) of Necitumumab plus Cisplatin-Pemetrexed versus Cisplatin-Pemetrexed Alone as First-Line Therapy in Stage IV Non-Squamous NSCLC (ID 2337)
10:40 - 10:50 | Author(s): L. Paz-Ares
- Abstract
- Presentation
Background
Necitumumab is a human IgG1 anti-EGFR1 monoclonal antibody that competes for the binding of natural ligands to this receptor and prevents receptor activation. EGFR1 is detectable in approximately 85% of advanced NSCLC tumors. This phase 3 study investigated necitumumab in combination with first-line chemotherapy in advanced non-squamous NSCLC.Methods
Patients with histologically or cytologically proven stage IV non-squamous NSCLC were randomized 1:1 to either Arm A: cisplatin 75mg/m[2] i.v.-pemetrexed 500mg/m[2] i.v. (Cis + PEM) on Day 1+ necitumumab 800mg i.v. on Days 1 and 8 of a 21-day cycle or Arm B: Cis+PEM alone. Patients received these regimens for up to six cycles. For patients in Arm A with at least stable disease, necitumumab continued until PD or intolerable toxicity. The primary endpoint was overall survival (OS). Secondary endpoints included progression-free survival (PFS), objective response rate (ORR), safety, and EGFR protein expression level by immunohistochemistry (H-score) utilizing archived tumor tissue based on a mandatory tissue collection. The planned sample size of this study was 947 patients (assuming a hazard ratio [HR] of 0.8 would allow 85% power at 2-sided alpha level of 0.05). After 633 patients, enrollment was stopped (after Feb 2011) following an Independent Data Monitoring Committee (IDMC) recommendation.Results
Between Nov 2009 and Feb 2011 633 patients were randomized (315 Arm A; 318 Arm B). Baseline characteristics were balanced between the arms; 67.0% were male and 33.0% female; ECOG-PS 0/1 94.2 % and PS 2 5.7 %. No difference between treatment arms was observed for OS (median 11.3 vs 11.5 months; HR 1.01 95%-CI [0.84, 1.21]), PFS (median 5.6 vs 5.6 months, HR 0.96 95%-CI [0.80, 1.16]) and ORR (31.1 vs 32.1%; Odds ratio 0.96 95%-CI [0.68, 1.34]). The exploratory analysis in 490 patients assessable for H-score revealed no association between H-score and differences in efficacy between treatment arms (H-score < 200: mOS 8.97 vs 9.72 months, HR 1.07, mPFS 4.90 vs 4.76 months, HR 0.95, ORR 27.1 vs 26.0%; H-score ≥ 200: mOS 15.01 vs 13.34 months, HR 1.03, mPFS 5.59 vs 5.62 months, HR 0.94, ORR 39.6 vs 39.4%). Grade ≥ 3 treatment-emergent adverse events (AEs) occurring more frequently in Arm A included skin or subcutaneous disorders (14.1 vs 0.3%), thromboembolic events (9.5 vs 6.4%), hypomagnesaemia (7.6 vs 2.2%), asthenia (6.9 vs 1.9%), vomiting (6.6 vs 3.2%), dyspnea (5.3 vs 2.6%) and diarrhea (4.3 vs 2.2%). The frequency of study drug related deaths was 4.9% and 2.9% in Arms A and B, respectively.Conclusion
In this study, the addition of necitumumab did not improve the efficacy outcome over cisplatin plus pemetrexed alone in advanced non-squamous-NSCLC. The EGFR H-score did not seem to predict the efficacy outcomes of necitumumab in combination with cisplatin plus pemetrexed. The addition of necitumumab resulted in a higher frequency of grade ≥ 3 AE (skin reaction, GI, asthenia and other) and an imbalance of grade ≥ 3 thromboembolic events. Further biomarker studies are ongoing.Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.
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O15 - NSCLC - Chemotherapy II (ID 109)
- Event: WCLC 2013
- Type: Oral Abstract Session
- Track: Medical Oncology
- Presentations: 1
- Moderators:G. Richardson, J.V. Heymach
- Coordinates: 10/29/2013, 10:30 - 12:00, Bayside Auditorium A, Level 1
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O15.06 - Randomized Phase III Trial of Gemcitabine (G)/Carboplatin (C) with or without Iniparib (I) in Patients (Pts) with Previously Untreated Stage IV Squamous Lung Cancer (ID 3322)
11:25 - 11:35 | Author(s): L. Paz-Ares
- Abstract
- Presentation
Background
Iniparib is an agent originally thought to function as an inhibitor of the DNA repair enzyme PARP-1, which is overexpressed in squamous lung cancers. Promising phase II activity and safety were reported with iniparib in combination with GC in pts with metastatic triple-negative breast cancer (O’Shaughnessy, NEJM 2011); however, subsequent phase III data were negative. Further study of iniparib’s mechanism of action suggests that this agent induces DNA damage, cell cycle arrest in the G2/M phase, and potentiates DNA-damaging chemotherapies not through PARP inhibition. Herein we report the final results from an international Phase III trial (NCT01082549) of first-line chemotherapy and iniparib in pts with advanced squamous lung cancer.Methods
Pts were randomized 1:1 to GC or GCI. All pts received G 1000 mg/m[2] IV days (D) 1 and 8, and C AUC=5 IV D1 of each 21-D cycle. Iniparib was dosed 5.6 mg/kg IV D 1, 4, 8, and 11. All pts were assessed for response per RECIST 1.1 every 6 weeks. Pts without evidence of progressive disease (PD) or other reason for discontinuation could remain on treatment beyond 6 cycles. Accrual of 780 pts provides 89% power to detect an improvement in survival from 8 months (mos) anticipated with GC to 10.7 mos with GCI (HR of 0.75). Eligibility: Pts with newly diagnosed stage IV (M1a and M1b) squamous lung cancer, ECOG PS 0-1. Exclusion criteria included: history of recent cardiac disease, untreated brain metastases, and treatment for early-stage lung cancer within 12 months of study entry. The primary endpoint was overall survival (OS). Interim analyses for safety and futility were performed by an independent data safety monitoring board.Results
780 pts were enrolled and randomized (GC, 390), (GCI, 390) from March 2010 to May 2012. Baseline characteristics were well balanced between groups (GC/GCI): median age 66 years (21-86); 74%/73% male; 30%/33% ECOG 0; 28%/33% current smokers; 66%/62% past smokers. The median number of cycles for GC/GCI were 4 (1-26)/5 (1-32). Dose reductions, dose intensity, and discontinuations due to tumor progression or adverse events were similar in both arms. The median OS for GC/GCI was 8.9 v. 8.9 months, HR 1.08 (0.92-1.28), p=.348. 1-year OS was 41 v. 40%. The median progression-free survival (PFS) for GC vs GCI was 4.9 v. 4.8 months, HR 0.99 (0.83-1.19), p=.92. The objective response rate (ORR) for GC v GCI was 34 v. 32%, p=.648. The safety profile was similar in both arms; anemia (28/26%), neutropenia (31/35%), thrombocytopenia (27/28%), and fatigue (6/9%).Conclusion
The addition of iniparib did not improve the efficacy of GC in the treatment of pts with advanced squamous lung cancer. Further development of iniparib in squamous lung cancer is not recommended.Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.
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P1.10 - Poster Session 1 - Chemotherapy (ID 204)
- Event: WCLC 2013
- Type: Poster Session
- Track: Medical Oncology
- Presentations: 1
- Moderators:
- Coordinates: 10/28/2013, 09:30 - 16:30, Exhibit Hall, Ground Level
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P1.10-017 - Clinical activity of lurbinectedin (PM01183) in combination with gemcitabine (GEM) in non-small cell lung cancer (NSCLC) patients (pts): preliminary subgroup analysis of a phase Ib study. (ID 995)
09:30 - 09:30 | Author(s): L. Paz-Ares
- Abstract
Background
PM01183 is an inhibitor of transactivated transcription and also acts on the tumor microenvironment. It lacks cross-resistance with platinum (Pt) agents. Evidence of synergism with GEM has been observed preclinically. PM01183 is undergoing intensive clinical evaluation as single agent in phase II studies in pancreatic, ovarian, breast and NSCLC pts. Its primary side effects are reversible myelosuppression and high emetogenic potential.Methods
Consenting adults with selected solid tumors (including NSCLC), age ≤ 75 years, Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1, adequate major organ function and up to 2 prior chemotherapy-containing (CT) lines were included in successive cohorts aiming to primarily define the recommended dose (RD) of PM01183 when combined with GEM, both on Days 1 and 8 every three weeks (q3wk). Prior GEM was not allowed in the metastatic setting. Available results exclusively from the NSCLC population are described here.Results
Recruitment was closed in December 2012. Overall, 22 of 45 treated pts (49%) had NSCLC. Of these, 73% were males. Median age was 65 years (r: 37-73). Patients received 1, 2 or 3 prior lines, in 64/27/9% of cases respectively. Non-squamous histology was reported in 91% of pts and 18% had known central nervous system (CNS) involvement. Five of 14 pts evaluable for efficacy by Response Evaluation Criteria In Solid Tumors (RECIST) v.1.1, responded to therapy [4 PRs and 1 CR], reaching an overall response rate (ORR) of 36% [95% confidence interval (CI): 13-65] in the RECIST evaluable population. Median response duration was 31 weeks (r: 7-52+). Eight of 22 pts were not evaluated for efficacy, as this was not the primary endpoint of the phase Ib study. Nevertheless, on an intention-to treat basis the ORR was 23% (95%CI: 8-45). Severe myelosuppression, G3/4 neutropenia or thrombocytopenia, was observed in 67/42% of pts, respectively. Other toxicities, in ≥ 10% of pts, were generally mild and comprised anemia, ALT/AST or creatinine increases, fatigue, mucositis, nausea/vomiting and anorexia. No alopecia was reported. Serious adverse events included febrile neutropenia (FN), pneumonia, sepsis and shock, and resulted in two treatment-related deaths, both occurred at dose levels over the RD. The RD was established at PM01183 3.0 mg + GEM 800 mg/m[2] on Days 1 and 8 q3wk.Conclusion
PM01183 and GEM combination resulted in relevant and durable clinical activity in NSCLC pts. Toxicity seems both manageable and predictable at the RD. The novel mechanism of action of PM01183, and particularly its lack of Pt cross-resistance are of special interest in this population. A randomized trial is ongoing to assess the role of this new CT combination in relapsed NSCLC.
