Journal Thoracic Oncology

Abstracts Journal of Thoracic Oncology • Volume 12 Issue S1 January 2017
favorable PFS. The OS data will be available soon.
Keywords: S-1, Cisplatin, Radiotherapy, docetaxel
POSTER SESSION 2 – P2.02: LOCALLY ADVANCED NSCLC
MULTIMODALITY TREATMENT –
TUESDAY, DECEMBER 6, 2016
P2.02-028 A PHASE I/II STUDY OF CARBOPLATIN, PEMETREXED,
AND CONCURRENT RADIATION THERAPY FOR PATIENTS WITH
LOCALLY ADVANCED NSCLC. CJLSG0912
Naohiko Murata 1 , Masashi Kondo 2 , Chiyoe Kitagawa 3 , Hideo Saka 3
1 Respiratory Medicine, Japanese Red Cross Nagoya Daini Hospital, Nagoya/Japan,
2 Respiratory Medicine, Nagoya University, Nagoya/Japan, 3 Respiratory Medicine,
National Hospital Organization Nagoya Medical Center, Nagoya/Japan
Background: A combined concurrent therapy with a platinum-based regimen
and radiation is recognized as a standard for patients with unresectable
stage III lung cancer. Though combined therapy has improved survival, little
improvement was reported after that for decades. Pemetrexed is a new
generation drug which is widely recognized as a safe and effective agent for
patients with stage IV lung cancer. Moreover pemetrexed is expected to have
a synergistic effect with radiation in vitro study. The purpose of this study
was to investigate safety and toxicity profile of a regimen of pemetrexed/
carboplatin (Pem/CBDCA) plus concurrent thoracic radiotherapy (TRT)
followed by consolidation therapy with Pem/CBDCA for Japanese patients
with unresectable non-small cell lung cancer (NSCLC). Methods: We planned
a multi-institutional open clinical phase I/II trial of Pem (500 mg/m 2 ) /CBDCA
(AUC=5) plus concurrent TRT for patients with stage IIIA/IIIB NSCLC. Patients
were administered two cycles of Pem/CBDCA with three-weeks interval and
delivered 60 Gy radiotherapy in 30 fractions concurrently. Additional two
cycles of Pem/CBDCA with a three-weeks interval were administered after the
safety of concurrent therapy was confirmed. Regarding a phase I study, we
confirmed a safety of this therapy every three consecutive patients. In case
that three or more DLTs in first six patients occurred, a dose of CBDCA was
to be decreased from AUC 5 to 4. We planned to enroll thirty patients in this
study in total of phaseIandII. Results: Six patients were included in the phase
I study. Median follow-up period was 27.4 month. DLTs were observed in two
out of six patients. This fulfilled preplanned criterion to conclude therapeutic
dose. The most frequent non-hematologic adverse event was esophagitis
(66.7%). Neutropenia was observed rather frequently (83.3%), but no
patients developed febrile neutropenia. As to two cases of DLT, one patient
experienced grade 2 radiation pneumonitis. The other patient presented
prolonged leukocytopenia. Other four patients completed scheduled therapy.
Five patients (83.3%) got PR. Two-year survival was 100%. Disease progression
was observed in three patients during study period. Because of slow accrual,
phase II study was not conducted. Conclusion: Present therapy is feasible
for Japanese patients with unresectable stage III NSCLC. Trial registration:
UMIN000008426
Keywords: Chemoradiotherapy, Safety, pemetrexed
POSTER SESSION 2 – P2.02: LOCALLY ADVANCED NSCLC
MULTIMODALITY TREATMENT –
TUESDAY, DECEMBER 6, 2016
P2.02-029 CONCOMITANT CHEMORADIOTHERAPY FOR LOCALLY
ADVANCED NON-SMALL CELL LUNG CANCER: A PHASE II STUDY
FROM THE GALICIAN LUNG CANCER GROUP
Susana Gómez 1 , Carmen Areses 2 , Natalia Fernandez 3 , Jorge Garcia 4 , Marinha
Costa 1 , Jose Luis Fírvida 2 , Begoña Campos 3 , Elena Hernandez 5 , Begoña
Taboada 6 , Enrique Castro 7 , Maria Veiras 8 , Javier Afonso 9 , Cristina Azpitarte 10 ,
Margarita Amenedo 11 , Joaquin Casal Rubio 12
1 Medical Oncology, Complexo Hospitalario Universitario de Vigo, Vigo/Spain,
2 Medical Oncology, Complexo Hospitalario Universitario de Ourense, Ourense/
Spain, 3 Medical Oncology, Complexo Hospitalario Universitario de Lugo, Lugo/
Spain, 4 Medical Oncology, Complexo Hospitalario Universitario de Santiago
de Compostela, Santiago de Compostela/Spain, 5 Radiotherapy, Complexo
Hospitalario Universitario de Vigo, Vigo/Spain, 6 Radiotherapy, Complexo
Hospitalario Universitario de Santiago de Compostela, Santiago de Compostela/
Spain, 7 Radiotherapy, Complexo Hospitalario Universitario de Ourense, Ourense/
Spain, 8 Radiotherapy, Centro Oncologico de Galicia, A´coruña/Spain, 9 Medical
Oncology, Complexo Hospitalario Universitario de Ferrol, Ferrol/Spain, 10 Medical
Oncology, Complexo Hospitalario de Pontevedra, Pontevedra/Spain, 11 Medical
Oncology, Centro Oncologico de Galicia, A´coruña/Spain, 12 Medical Oncology,
Complejo Hospitalario Universitario de Vigo, Vigo/Spain
Background: Concomitant platinum-based ChemoRadiotherapy (CT-RT) is the
recommended treatment for unresectable locally advanced Non-Small Cell
Lung Cancer (NSCLC). We conducted a phase II study to evaluate the efficacy
and safety of concomitant CT-RT with cisplatin (C) and intravenous and oral
vinorelbine (V) and thoracic radiotherapy. Methods: 31 chemo-naive patients
with histologically confirmed inoperable locally advanced NSCLC, stage IIIA
(T4 or N2)/IIIB, PS 0-1 and adequate lung function (FEV1 > 1.1, V20 < 30%) were
included in concomitant CT-RT with: C 80 mg/m2 day 1 and intravenous V 25
mg/m2 day 1 and oral V 25 mg/m2 day 8 for three cycles, during conformal
thoracic radiotherapy (66 Gys, 180 cGy/day). The primary objective was overall
survival (OS); secondary objectives were progression free survival (PFS),
response rate (RR) and toxicity. Median follow-up: 18,1 months. Results: The
patients characteristics were: mean age 59,6 years (44-75); male/female: 26/5;
ECOG PS 0/1: 5/26; adeno/squamous/large cell carcinoma: 15/12/4; stage IIIA
16 patients and stage IIIB 15 patients. 28 patients were evaluable for response
(3 patients in treatment) and 31 for toxicity. RR: 3 CR, 18 PR (RR 75%; 95% CI:
59-91), 5 SD (17.8%) and 2 PD (7.2%). The median PFS was 12 months (95% CI:6-
18) and median OS was 28 months (95% CI:21-34). The PFS at 1/3 years were
47%/20% and the OS at 1/3 years were 77%/45%. Main toxicities (NCI-CTC
4.0) per patient in CT-RT (89 cycles of chemotherapy, 2.9 per patient; mean
doses RT: 65,4 Gys) grade 1-2/3-4 (%) were: neutropenia 32/22.5; anemia 39/10;
thrombocytopenia 13/0; nausea/vomiting 31/3; fatigue 29/0; esophagitis 39/6
and pneumonitis 16/0; hospitalizations was necesary in 9 patients: febrile
neutropenia in 3 patients and grade 3 esophagitis in 2 patients. Conclusion:
Concomitant CT-RT with Cisplatin and intravenous and oral Vinorelbine during
thoracic radiotherapy is a feasible treatment option for inoperable locally
advanced stage III NSCLC, showing good clinical efficacy and tolerability with
acceptable long-term survival.
Keywords: Concomitant Chemoradiotherpay, locally advanced non-small cell
lung cancer
POSTER SESSION 2 – P2.02: LOCALLY ADVANCED NSCLC
MULTIMODALITY TREATMENT –
TUESDAY, DECEMBER 6, 2016
P2.02-030 CONSOLIDATION CHEMOTHERAPY FOLLOWING
CONCURRENT CHEMORADIATION FOR STAGE III NON-SMALL CELL
LUNG CANCER: A BRAZILIAN MULTICENTRIC COHORT
Vladmir Cordeiro De Lima 1 , Clarissa Baldotto 2 , Carlos Barrios 3 , Eldsamira
Sobrinho 4 , Mauro Zukin 2 , Clarissa Mathias 4 , Facundo Zaffaroni 5 , Rodrigo
Nery 1 , Gabriel Madeira 6 , Alex Amadio 7 , Guilherme Geib 8 , Juliano Coelho 9 , Maria
Fernanda Simões 4 , Gilberto De Castro Jr 7
1 Medical Oncology, A C Camargo Cancer Center, Sao Paulo/Brazil, 2 Instituto Coi de
Educação E Pesquisa, Rio de Janeiro/Brazil, 3 Medicine, Pucrs School of Medicine,
Porto Alegre/Brazil, 4 Núcleo de Oncologia Da Bahia, Bahia/Brazil, 5 Statistics,
Latin America Cooperative Oncology Group (Lacog), Porto Alegre/Brazil, 6 Medical
Oncology, Instituto Nacional Do Câncer (Inca), Rio de Janeiro/Brazil, 7 Instituto Do
Câncer Do Estado de São Paulo, Faculdade de Medicina Da Usp, São Paulo/Brazil,
8 Medical Oncology, Hospital de Clínicas de Porto Alegre, Porto Alegre/Brazil,
9 Hospital de Clínicas de Porto Alegre, Porto Alegre/Brazil
Background: Locally advanced stage III grossly accounts for 25% newly
diagnosed non-small cell lng cancer (NSCLC) cases. Albeit some patients (pts)
are amenable to surgical resection, most will be treated with concurrent
chemoradiation (CRT), whilst the addition of consolidation chemotherapy
(CC) is still a debatable topic. We decided to look into the impact of CC in
stage III NSCLC Brazilian pts treated in the daily clinical practice. Methods:
We retrospectively collected data of stage III NSCLC pts treated in five
different Brazilian cancer institutions from Jan/2007 to Dec/2011, whom
have received CRT followed or not by CC. Eligible pts were ≥18yo and must
have been treated with cisplatin or carboplatin plus etoposide, paclitaxel or
vinorelbine, concurrently with thoracic irradiation (RT). Patients treated with
surgery or neoadjuvant chemotherapy were excluded. Primary endpoint was
overall survival (OS) from the date of diagnosis. Association between CC and
clinical variables and demographics were evaluated by Pearson´s Chi-square
test (Χ²). Survival curves were calculated by Kaplan-Meier method and
compared by log-rank test. Univariate and multivariate analysis were made
using Cox proportional model (CPM). P-values5% and ECOG-PS 2 were
observed in 39.1% (n=61) and 14.6% (n=24), respectively. Median follow-up
was 25 mo. CC was administered to 27 pts. The only variable associated with
CC was T stage (Χ²(4) = 11.410, p=0.022), with more T3 tumors receiving CC
than expected. We observed no statistically significant difference in OS
between patients treated or not with CC (p=0.211), although 3-year OS rate
was numerically higher in CC pts (40% vs. 31%). Median OS in was 24 and 25
months in CC and no CC groups, respectively (HR 1.408, 95%CI 0.814-2.434). A
total delivered RT dose ≥ 61Gy was the only variable independently associated
with improved survival (HR 0.617, 95%CI 0.419-0.909, p=0.012). Conclusion: CC
did not improve OS in stage III NSCLC patients after concurrent CRT. RT dose <
S452 Journal of Thoracic Oncology • Volume 12 Issue S1 January 2017