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K. Pittman
Moderator of
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MO25 - NSCLC - Combined Modality Therapy II (ID 112)
- Event: WCLC 2013
- Type: Mini Oral Abstract Session
- Track: Mesothelioma
- Presentations: 11
- Moderators:T. Le Chevalier, K. Pittman
- Coordinates: 10/30/2013, 10:30 - 12:00, Parkside Ballroom B, Level 1
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MO25.01 - Interim analysis of the Spanish Lung Cancer Group (SLCG) randomized phase II trial of thoracic radiotherapy (RT) concurrent with cisplatin (P) plus oral vinorelbine (OV) or etoposide (E) for unresectable locally advanced (LA) stage III non-small cell lung cancer (NSCLC). (GECP10/02). (ID 2658)
10:30 - 10:35 | Author(s): D. Isla, R. De Las Peñas, N. Martinez-Banaclocha, B. Massuti, M.A. Sala, I. Bover, R. Marse, A. Insa, T. Moran, A. Artal, P. Diz, J. Gomez-Codina, A.L. Ortega, V. Gutierrez, J. Muñoz, M. Alvarez De Mon, C. Camps, R. Garcia-Gomez, J.M. Jurado, S. Ponce-Aix, M. Provencio
- Abstract
- Presentation
Background
Chemoradiation is the standard of care for the treatment of unresectable LA-NSCLC. Cisplatin plus either etoposide or vinorelbine are two of the chemotherapy (CT) regimens widely used for the disease concurrently with radiotherapy. Oral vinorelbine is a formulation which has achieved comparable results to the IV vinorelbine. The purpose of the study is to evaluate the efficacy and safety of cisplatin when combined with etoposide or oral vinorelbine with radical radiation for the management of stage III NSCLC.Methods
Patients (pts) between 18 and 75 years, with histologically proven untreated and unresectable LA stage IIIA/IIIB NSCLC, adequate bone marrow, hepatic and renal function, ECOG PS 0-1, were randomized to: Arm OV-P: OV 60 mg/m[2] D1, D8 cycle 1 and 80 mg/m[2] cycle 2 (if no grade 3-4 toxicity) plus P 80 mg/m[2] D1 every 3 weeks for 2 cycles as induction; patients without progression received OV 40 mg/m[2] D1, D8, and P 80 mg/m[2] D1 every 3 weeks for 2 more cycles (4 cycles in total). Arm E-P: E 50 mg/m[2] intravenously D1 to D5 plus P 50 mg/m[2] D1, D8 every 4 weeks for 2 cycles. Both regimens administered with concurrent RT 66 Gy in 6.5 weeks. The primary endpoint was progression free survival using RECIST 1.1, and secondary endpoints were overall response rate, overall survival, and safety profile. To guarantee an overall type-1 α error (one side) no greater than 0.05 and a type II (β) error 0.1 for the primary endpoint of PFS, a sample size of 134 pts allocated in a 1:1 ratio is planned.Results
Since August 2011 77 pts have been recruited. 46 pts have been included in the interim analysis, 23 pts have been randomly allocated to each treatment arm. Patient’s characteristics were: Male 91.3%; median age 64 (range 44-75); PS1 56.5%; smokers 46.8%; adenocarcinoma 40.4% / squamous 55.3%; stage IIIA 46.8% / IIIB 53.2%. Median of months between initial diagnosis and study start was 1 (range 0.3-15.7). Safety: 118 cycles (cy) were analysed, 79 in arm OV-P and 39 in arm E-P. Hematological toxicities arms OV-P/E-P (% cy): grade (g) 3/4 neutropenia 8.9%/13.1%; g3 thrombocytopenia 0%/5.3%; g3 anemia 0%/2.6%; febrile neutropenia 3 cases on OV-P arm (all during induction CT on cy 1) and 1 case on E-P arm (during concurrent chemoradiation). Non-hematological toxicities arms OV-P/E-P (% cy): g3 esophagitis/mucositis 1.3%/15.5%; g3 infection without neutropenia 1.3%/5.1%. No treatment-related deaths were reported. There was no remarkable difference in other toxicities between both arms. 39 pts completed the treatment as per protocol, 19 in arm OV-P and 20 in arm E-P. Overall response rates were 73.7% and 50% for the OV-P and the E-P arm, respectively.Conclusion
This interim analysis shows that OV-P and E-P when administered concurrently with RT have a manageable safety profile with efficacy. Safety data is consistent with other studies reported for both chemoradiation regimens. Based on these positive results for safety, accrual is ongoing. Clinical trial information EudraCT 2010-022927-31.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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MO25.02 - Thoracic Radiotherapy With or Without Concurrent Daily Low-Dose Carboplatin in Elderly Patients With Locally Advanced Non-small Cell Lung Cancer: Updated Results of the JCOG0301 and Pooled Analysis With the JCOG9812 Trial. (ID 734)
10:35 - 10:40 | Author(s): S. Atagi, A. Yokoyama, H. Okamoto, T. Takahashi, Y. Ohe, T. Sawa, H. Semba, K. Takeda, N. Nogami, K. Mori, K. Nakagawa, M. Harada, S. Kudoh, Y. Tomizawa, Y. Takeda, T. Hida, N. Katakami, S. Ishikura, T. Shibata, H. Fukuda, T. Tamura
- Abstract
- Presentation
Background
The Japan Clinical Oncology Group (JCOG) undertook 2 randomized phase III trials (JCOG9812 and JCOG0301) to assess whether daily low-dose carboplatin plus radiotherapy could improve survival in elderly patients with stage III non-small cell lung cancer (NSCLC) when compared to radiotherapy alone. Although JCOG9812 was prematurely terminated because of a high incidence of treatment-related deaths (TRDs) and instances of protocol violation, especially with regard to radiotherapy planning, the trial regimen was assumed promising. Therefore, JCOG0301 was conducted for the same subjects using the same protocol regimen with modified inclusion criteria regarding pulmonary function and radiotherapy quality control (RTQC) measures. We then carried out a preplanned pooled analysis of these 2 studies.Methods
The eligibility criteria for both trials were age of ≥71 years and unresectable stage III NSCLC. Patients were randomized to receive radiotherapy alone (60 Gy, RT arm) or chemoradiotherapy (radiotherapy, 60 Gy plus concurrent carboplatin, 30 mg/m[2] per fraction up to the first 20 fractions, CRT arm). The primary endpoint for both studies was overall survival (OS). The pooled analysis included OS, progression-free survival (PFS), response rate, and toxicities.Results
In JCOG9812, 46 patients (RT arm, n=23; CRT arm, n=23) were enrolled from November 1999 to August 2001. In JCOG0301, 200 patients (RT arm, n=100; CRT arm, n=100) were enrolled from September 2003 to May 2010, and in total, 246 patients were included in the pooled analysis. Patient characteristics for the RT (n=123) and CRT (n=123) arms were as follows: median age, 77 years (range, 71–93) and 77 years (range, 71–89); stage IIIA/IIIB, 65/58 patients and 63/60 patients; performance status (PS) 0/1/2, 44/74/5 patients and 50/69/4 patients; men/women, 103/20 patients and 96/27 patients, respectively. The median OS for the RT (n=121) and CRT (n=122) arms were 16.3 months (95% CI, 13.4–18.6) and 20.7 months (95% CI, 16.3–26.9), respectively (HR, 0.672; 95%CI, 0.502–0.898, stratified log-rank test one-sided p=0.0034). The pooled HR for PFS was 0.671 (95%CI, 0.514–0.875, stratified log-rank test one-sided p=0.0015). Response rates for the RT and CRT arms were 46.3% and 53.3%, respectively. The number of patients with grade 3/4 hematological toxicities was higher in the CRT arm than in the RT arm: leucopenia (62.2% vs 1.7%), neutropenia (54.6% vs none), and thrombocytopenia (30.3% vs 3.3%). The incidence of grade 3/4 pneumonitis decreased from 4.4% (JCOG9812; RT, 4.5% and CRT, 4.3%) to 2.1% (JCOG0301; RT, 3.1% and CRT, 1.0%), and that of late lung toxicity, from 14.0% (JCOG9812; RT, 10.0% and CRT, 17.4%) to 5.9% (JCOG0301; RT, 5.3% and CRT, 6.5%). The incidence of TRD also decreased from 8.9% (JCOG9812; RT, 1 patient and CRT, 3 patients) to 3.6% (JCOG0301; RT, 4 patients and CRT, 3 patients). As per subgroup analyses, ≤75 years, stage IIIA, male, PS 0, and smoking history were associated with statistically significant improvement in OS in the CRT arm.Conclusion
This combination chemoradiotherapy for elderly patients with locally advanced NSCLC provides clinically significant benefits and RTQC measures are imperative to improve treatment outcome.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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MO25.03 - Safety data from a Phase II study of pemetrexed (PEM) and cisplatin (CIS) with concurrent thoracic radiation after PEM+CIS induction in patients with unresectable locally advanced (LA) Non Squamous Non-Small Cell Lung Cancer (NS-NSCLC) (ID 226)
10:40 - 10:45 | Author(s): P. Garrido, M. Serke, S. Novello, P. Giraud, C. Visseren-Grul, S. Ameryckx, V. Soldatenkova, N. Chouaki, W. Engel-Riedel
- Abstract
- Presentation
Background
This single-arm multicenter Phase II study investigated the efficacy and safety of PEM+CIS induction chemotherapy (CT) followed by full-dose PEM+CIS with concurrent radiotherapy (RT) in patients with LA NS-NSCLC. The 1-year progression-free survival (PFS) rate (primary endpoint) was 51.3% (ESMO 2013). Here, we report the safety data for induction CT and concurrent CT+RT.Methods
Patients with unresectable Stage IIIA/IIIB NS-NSCLC (AJCC Version 6), ECOG-PS 0-1 and forced expiratory volume (FEV) >50% of predicted normal FEV received 2 cycles of PEM 500mg/m[2] + CIS 75mg/m[2] on Day 1, every 21 days. Patients who did not progress, with no residual neurological toxicity >Grade (G)2, ECOG-PS 0-1 and lung V20<35% were candidates to receive 2 cycles of the same full-dose PEM+CIS regimen with concurrent thoracic RT of 2Gy/fraction, 5d/week for 7wks (66Gy total). All patients received vitamin supplementation/dexamethasone prophylaxis as per PEM-label.Results
90 patients were enrolled in 4 European countries, 75 (83.3%) completed induction CT and started concurrent CT+RT. Characteristics of 90/75 patients starting induction/concurrent therapy: median age 61/62yrs, male 57%/53%, ECOG-PS 0 66%/65%, mean(SD) FEV 2.3(0.62)/2.3(0.59)L, adenocarcinoma 90%/92%, Stage IIIA 36%/37%. 63 of 75 patients starting concurrent CT+RT (84.0%) received all 4 CT cycles and full dose RT. Median PEM+CIS dose intensities were 90-92% during induction and >97% during concurrent CT+RT, median RT dose was 66Gy (only 6 patients <60Gy). One patient died from study-drug-related toxicity (enteritis) during Cycle 4. Four patients discontinued due to non-fatal drug- or radiation-related adverse events (AEs), 1 on induction CT (renal failure), 3 on concurrent CT+RT (hypoacusis, 2 patients with radiation esophagitis). During induction/concurrent therapy, 8 of 90 patients (8.9%)/12 of 75 patients (16.0%) had ≥1 CT dose delay due to AEs, mainly neutropenia (n=5/6). 2/6 patients (2.2%/8.0%) required CT dose reductions. 13 of 75 patients (17.3%) experienced AEs requiring interruption of radiation, mainly radiation esophagitis (9.3%). Common G1-4 toxicities are presented in the table. 41.3% of patients reported ≥1 G3/4 toxicity during concurrent CT+RT, mainly esophagitis (12.0%), neutropenia (10.7%) and leukopenia (9.3%). G3 mucositis, G3 dysphagia and G3 acute pneumonitis were each reported by 1 patient (1.3%); 6 patients (8.0%) required blood-cell transfusions. Figure 1Conclusion
PEM+CIS induction CT followed by full-dose PEM+CIS with concurrent thoracic RT was well tolerated in this study. Incidences of both G3/4 and low-grade toxicities were low, not only during PEM+CIS induction CT, but also during the subsequent 2 cycles of full-dose PEM+CIS CT with concurrent thoracic RT.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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MO25.04 - Phase II study comparing Cisplatin/Etoposide and weekly Paclitaxol/Carboplatin regimens with concurrent thoracic radiotherapy in patients with locally advanced non-small cell lung cancer (ID 67)
10:45 - 10:50 | Author(s): J. Liang, W. Wang, G. Ou, Z. Hui, M. Chen, S. Wu, C. Lv, L. Zhao, Y. Xu, A. Shi, L. Wang
- Abstract
- Presentation
Background
To evaluate the effect and safety of concurrent thoracic radiotherapy (TRT) with Cisplatin/Etoposide (PE) compared with weekly Paclitaxol/Carboplatin (PC) regimens in patients with stage III non-small cell lung cancer (NSCLC).Methods
Patients with stage III NSCLC were randomly assigned to receive PE regimen (PE arm) cisplatin 50mg/m[2] d1, 8, 29 and 36, etoposide 50mg/m[2] d1-5 and 29-33 concurrent with TRT 60Gy, or PC regimen (PC arm) carboplatin (AUC=2) and paclitaxol 45mg/m[2] concurrent with TRT 60Gy.Results
156 patients were registered. Eventually, 149 were assigned to PE arm (73) and PC (76). The median follow-up time was 38 months. The median survival time (MST) was 20 months. The 2-year overall survival (OS) and 3-year OS were 39.8% and 32.9%. The 2-year progress free survival (PFS) and 3-year PFS were 24.8% and 22.4%. The MST of PE arm and PC arm were 22 months and 20 months, and the median progress free time were 13 months and 11months, respectively. The 2-year OS of PE arm and PC arm were 44.9% and 35%, the 3-year OS were 40% and 26.2% (p=0.323), respectively. The 2-year PFS of PE arm and PC arm were 27.7% and 22.1%, 3-year PFS were 24.5% and 20.5% (p=0.449), respectively. The incidence of Great 3/4 bone marrow depression of PE arm and PC arm were 34.2% and 23.7% (p=0.29). The incidence of Great 2 or greater radiation pneumonitis of PE arm and PC arm were 19.2% and 26.3% (p=0.059).Conclusion
For stage III NSCLC, concurrent TRT with PE regimen has improved PFS and OS comparing with PC regimen without significant difference. Concurrent PE regimen has a lower incidence of Great 2 or greater radiation pneumonitis.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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MO25.05 - DISCUSSANT (ID 3947)
10:50 - 11:05 | Author(s): R.P. Abratt
- Abstract
- Presentation
Abstract not provided
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MO25.06 - Phase I/II trial of recombinant human endostatin in combination with concurrent chemo-radiotherapy in the patients with stage III non-small-cell lung cancer (ID 2325)
11:05 - 11:10 | Author(s): M. Chen, Y. Bao, F. Peng, Q.C. Zhou, Z.H. Yu, J.C. Li, Z.B. Cheng, L. Chen, X. Hu, Y.Y. Chen, J. Wang, H.L. Ma
- Abstract
- Presentation
Background
Endostatin has been proved to be a potent endogenous angiogenic inhibitor. Recombinant human endostatin (Endostar) was reported to be efficient in blocking angiogenesis and suppressing tumor growth. Preclinical studies demonstrated that Endostar could normalize tumor vasculature, alleviate hypoxia and sensitize the function of radiation. This study was conducted to evaluate the efficacy and safety of Endostar combined with concurrent chemo-radiotherapy (CCRT) in patients with stage IIInon-small-cell lung cancer (NSCLC).Methods
Patients with unresectable stage IIINSCLC were eligible. Patients received Endostar (7.5 mg/m[2]/d) through 7 days at weeks 1, 3, 5, and 7, and two cycles of docetaxel (65 mg/m[2]) and cisplatin (65 mg/m[2]) on days 8 and 36, with concurrent thoracic radiation at 60~66 Gy. Primary end points included the short-term efficacy and treatment-related toxicity of Endostar combined with CCRT.Results
In all, 50 patients were enrolled onto the study, and 48 were assessable. Median follow-up was 32.1 months. Response rate was 77%. The estimated median progression-free survival (PFS) was 10.2 months and the estimated median overall survival (OS) was 22.6 months. The 1-year and 2-year PFS rates were 48% and 25%, respectively. The 1-year and 2-year OS rates were 81% and 47%, respectively (Figure 1).Nine patients (19%) experienced grade 3 or higher treatment-related nonhematologic adverse events (AEs). Predominant nonhematologic toxicities were grade 3 esophagitis (n = 4; 8%), and grade 3 to 5 pneumonitis (n = 6; 13%). The rates of observed grade 3 and 4 hematologic AEs were 77% (n = 37). The predominant hematologic toxicity was grade 3 to 4 lymphopenia (n = 32; 67%) and neutropenia (n = 23; 48%). Overall, the entire treatment regimen was well tolerated. Figure 1 Figure 1Conclusion
The combination of Endostar with CCRT is feasible and shows promising activity. This regimen should be studied further in patients with locally advanced NSCLC.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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MO25.07 - Early onset body weight loss during concurrent chemo-radiotherapy for non-small cell lung cancer is not due to dysphagia or reduced calorie intake (ID 3409)
11:10 - 11:15 | Author(s): C. Op Den Kamp, D. De Ruysscher, R. Houben, C. Oberije, G.P. Bootsma, W. Geraedts, C. Pitz, R. Langen, E. Wouters, A. Dingemans, A. Schols
- Abstract
- Presentation
Background
Increased treatment-associated esophagitis could be responsible for concurrent chemo-radiotherapy (CT-RT)-induced weight loss in patients with non-small cell lung cancer (NSCLC). However, based on clinical observations, we hypothesized that weight loss already starts early after initiation of concurrent CT-RT and might therefore be not solely dependent on decreased intake due to esophagitis symptoms.Methods
In a retrospective cohort, the onset and frequency of weight changes and their association with esophagitis grade ≥2 were assessed in patients with NSCLC treated with concurrent (n=102) or sequential (n=92) CT-RT. The findings in the retrospective cohort were validated in a prospective study in which weight loss and esophagitis grade ≥2 was assessed over a longer time period and additional data on nutritional intake, muscle strength and quality of life was obtained of patients treated with concurrent CT-RT (n=9).Results
In the retrospective cohort, both the number of patients with weight loss and the magnitude of weight loss was significantly higher in concurrent than sequential treated patients in week 2, 3 and 4 of (CT-)RT (p<0.05). Longitudinal data analysis showed no significant associations between weight loss and grade esophagitis ≥2 in patients treated with concurrent CT-RT (p=0.10). In the prospective cohort, a similar pattern of ‘early’ weight loss was observed in the first weeks of concurrent CT-RT (p<0.05). This early weight loss was not accompanied by significant decreases in nutritional intake but muscle strength did already decline in this early stage (p<0.05). In the following weeks of concurrent CT-RT, the weight further decreased and reached its minimum at the end of treatment (p<0.05), while the number of patients with grade esophagitis ≥2 increased during this time period. During the later part of concurrent CT-RT, dietary intake was significantly lower and patients became more reliant on supplemental nutrition (p<0.05). Although the weight increased again in the weeks after concurrent CT-RT, it had still not reached the baseline level after 4 weeks post treatment (p<0.05).Conclusion
Weight loss is a common complication of concurrent CT-RT for locally advanced NSCLC, starts early after initiation of CT-RT and is not dependent of esophagitis. It is presumably caused by active catabolism as this ‘early’ weight loss is accompanied by decreased muscle strength, despite stable dietary intake. In the later weeks of treatment, concurrent CT-RT is characterized by a further decline in body weight, decreased dietary intake and higher reliance on nutritional support. In this phase the occurrence of radiation-induced esophagitis grade ≥2 increases. In the weeks following concurrent CT-RT, partial recovery of body weight takes place but this is still not complete after 4 weeks post CT-RT. The sustained weight loss during and following concurrent CT-RT might have major negative consequences as weight loss in patients with underlying malignant disease might has been associated with higher mortality, lower treatment responses and decreases in quality of life. Though the origin of weight loss during concurrent CT-RT seems to be different in the subsequent phases, more aggressive supportive nutritional support throughout the treatment course seems conceivable to prevent negative energy balances and optimize concurrent CT-RT management.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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MO25.08 - Impact of Pretretment Leukocytosis on Prognosis in Locally Advanced Non-Small Cell Lung Cancer Patients Treated with Concurrent Chemoradiotherapy (ID 1831)
11:15 - 11:20 | Author(s): E. Topkan, C. Parlak, O.C. Guler, B. Pehlivan, U. Selek
- Abstract
Background
In this study, impact of high pretreatment white blood cell count (WBCC) on survival outcomes in locally advanced non-small cell lung cancer (LA-NSCLC) patients treated with concurrent chemoradiotherapy (CRT) was investigated.Methods
Medical records of LA-NSCLC patients treated with definitive CRT at our department between dates January 2007 and December 2011 were retrospectively evaluated. All patients received 60-66 Gy thoracic radiotherapy concurrently with 1-3 cycle cisplatin-vinorelbine/taxane (q21) regimen chemotherapy. Patients were divided into two groups according to pretreatment basal WBCC: Group1: normal (4.000-11.000) and Group 2: high (>11.000). These two groups are compared in terms of overall survival (OS), and progression-free survival (PFS).Results
Pretreatment characteristics of 718 patients were given in Table 1. At a median follow-up of 23.2 months (range 8.8-44.6), median OS and PFS for whole group were 20.6 (%95 CI: 19.3-21.9) and 9.9 months (%95 CI: 9.4-10.1), respectively. On comparative survival analyses, patients with high pretreatment WBCC had inferior OS (22.8 vs.14.7 months; p<0.001) and PFS (10.4 vs. 7.0 months; p<0.001) than those with normal WBCC. On univariate analyses, T-stage (T1-2 vs. 3-4; p=0.035), N-stage (N2 vs. N3; p=0.002), and pretreatment WBCC (4.000-11.000 vs >11.000; p<0.001) were the significant prognostic factors. These factors also retained their significance on multivariate analyses as well (p<0.05 for each). Table. Pretreatment patients characteristicsCharacteristics Whole Group (n=718) Group 1 (n=555) Group 2 (n=163) P value Median age (Years) Range 54.0 31-69 53 33-64 54 31-69 0.28 Sex [N,(%)] Female Male 246 (34.3) 472 (65.7) 51 (7.1) 112 (15.6) 195 (27.2) 360 (50.1) 0.39 Performance Status [N,(%)] ECOG 0 ECOG 1 314 (43.7) 404 (56.3) 73 (10.2) 90 (12.5) 241 (36.6) 314 (43.7) 0.78 Histology [N,(%)] Squamous cell Adenocancer 388 (54.0) 330 (46.0) 92 (12.8) 71 (9.9) 296 (41.2) 259 (36.1) 0.53 TN stage T1N3 T2N3 T3N3 T4N2 T4N3 73 (10.2) 115 (16.0) 292 (40.7) 123 (17.1) 115 (16.0) 17 (2.4) 26 (3.6) 51 (7.1) 28 (3.9) 41 (5.7) 56 (7.8) 89 (12.4) 241 (33.6) 95 (13.2) 74 (10.3) 0.11 Conclusion
Worse survival outcomes observed in patients with pretreatment WBCC above the reference limits suggest that pretreatment WBCC may be a potentially cheap and relevant independent prognostic factor that can be used besides other well-known factors to predict treatment outcomes in LA-NSCLC patients treated with definitive CRT. -
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MO25.09 - A Phase II study of <sup>18</sup>F-FDG PET guided optimization of neoadjuvant chemotherapy for resectable non-small cell lung cancer (ID 2442)
11:20 - 11:25 | Author(s): J.E. Chaft, M.D. Hellmann, M. Dunphy, W. Jappe, C.S. Sima, R.J. Downey, W.D. Travis, C.G. Azzoli, M.G. Kris
- Abstract
- Presentation
Background
Perioperative chemotherapy improves overall survival in patients with resectable non-small cell lung cancers. In contrast to adjuvant chemotherapy, neoadjuvant chemotherapy enables radiographic assessment of chemotherapy effect and hence, the option to switch non-responding patients to a potentially more effective regimen. Responses to neoadjuvant chemotherapy assessed by PET imaging correlate better with clinical outcomes than does CT imaging. We have initiated a Phase II trial of PET response guided chemotherapy, where chemotherapy administration decisions are based on comparisons of baseline PET imaging, imaging after 2 cycles of platinum-based chemotherapy, and imaging after ‘switch’ chemotherapy in patients with an initial suboptimal response.Methods
This Phase II trial (NCT01443078) is enrolling patients with clinical Stage IB-IIIA non-small cell lung cancers deemed operable by a thoracic surgeon. To be eligible, the primary lung mass must be >2 cm with a SUV ≥4.5. Patients with diabetes requiring insulin are excluded. Patients are initially treated with cisplatin (or carboplatin if cisplatin ineligible) + gemcitabine (squamous cell) or pemetrexed (non-squamous). After 2 cycles, if repeat PET imaging shows less than a 35% decrease in SUV of the primary tumor, patients are switched to vinorelbine + docetaxel every 2 weeks with pegylated filgrastim support (2 doses = 1 cycle). The primary endpoint of this study is partial metabolic response after 2 cycles of switch vinorelbine + docetaxel as assessed by PERCIST (SUV decrease of ≥30% using the pre-switch scan as the new baseline). We considered a >20% partial metabolic response rate in those who received vinorelbine + docetaxel worthy of further study. Therefore this study was powered to see at least 6 of 25 partial metabolic responses to vinorelbine + docetaxel, estimating a total patient accrual of 100 patients.Results
27 patients have been enrolled. 5 are undergoing platinum-based chemotherapy and have not yet been reassessed. 22 patients have been reimaged after 2 cycles of platinum-based chemotherapy, 13 (59%) have had a > 35% decrease in SUV and continued on platinum-based chemotherapy. 9 (41%) patients have had a <35% decrease in SUV after platinum-based therapy and were assigned to switch chemotherapy. 7 received vinorelbine + docetaxel, and 5 (71%, 95% CI 29-96%) have had a PERCIST partial metabolic response after 2 cycles, 1 progressive disease and 1 is pending reassessment. 17 patients have been surgically explored with 13 (76%) R~0~ resections.Conclusion
Preliminary results from this ongoing trial suggest that patients with resectable non-small cell lung cancers who have a suboptimal PET-assessed response to standard histology-selected, platinum-doublet neoadjuvant chemotherapy can be effectively treated with vinorelbine and docetaxel followed by surgery. This study is on-going. Assessment of pathologic response in resected patients and clinical follow-up in all patients will be available by the time of presentation.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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MO25.10 - A Phase II trial of mid-treatment FDG-PET adaptive, individualized radiation therapy plus concurrent chemotherapy in patients with inoperable non-small cell lung cancer (NSCLC) (ID 3461)
11:25 - 11:30 | Author(s): F.(. Kong, R.T. Haken, M. Schipper, J. Hayman, N. Ramnath, M. Matuszak, K. Hassan, T. Ritter, N. Bi, W. Wang, M. Orringer, K. Cease, T.S. Lawrence, G. Kalemkerian
- Abstract
- Presentation
Background
We hypothesized that individualized radiation treatment targeting to the FDG-avid tumor identified mid-treatment would improve local tumor control.Methods
This is a phase II trial for patients with inoperable/unresectable NSCLC. Conformal radiotherapy (RT) was given in 30 daily fractions. RT dose was individualized to a fixed rate of grade >2 lung toxicity and adaptively escalated to the residual tumor on mid-tx FDG-PET upto a total dose of 86 Gy. Patients were given concurrent weekly followed by consolidation carboplatin/paclitaxel. The primary endpoint was local-regional tumor control (LRTC) and local-regional progression free survival (LRPFS) at 2 years.Results
42 patients were enrolled: median age 63 years (range 45-83); 28 (67%) male; 39 (93%) smokers; 38 (92%) stage III; and 45% squamous cell. Median physical dose reached was 83 Gy (range 63-86 Gy), equivalent to 90 Gy in 2 Gy fractions (biological effective dose 107 Gy). Minimum and median follow-up were 9 and 27 months, respectively. The 2-year rates of in-field LRTC, overall LRTC, and LR-PFS were 84% (62-94%), 61% (39-77%), and 37% (22-52%), respectively. 15 patients progressed: 2 (13%) at primary tumor alone; 4 (27%) first at distant sites alone; 2 (13%) at nodal regions alone; 5 (33%) at both distant sites and nodal regions; 1 (7%) at both distant site and primary tumor; 1 (7%) at both nodal region and primary tumor. Median overall survival was 22 months (10-33 months) and 2-year overall survival rate was 49% (32-63%). These results compared favorably to stage-matched patients treated with standard-dose RT in our center 2-year overall survival 23% (8-41%) during the same time period.Conclusion
Adapting RT by targeting high dose radiation to the FDG avid region detected mid-treatment provides outstanding 2-year local-regional tumor control. RTOG 1106 is currently testing this regimen in a randomized fashion.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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MO25.11 - DISCUSSANT (ID 3948)
11:30 - 11:45 | Author(s): K. Kubota
- Abstract
- Presentation
Abstract not provided
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