Phase II trial: Concurrent chemotherapy and radiotherapy with nitroglycerin in locally advanced non-small cell lung cancer patients.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 7068-7068
Author(s):  
Dolores De la Mata ◽  
Monika Blake ◽  
Jesus Zamora Moreno ◽  
Omar Pena ◽  
Diana Flores-Estrada ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Phase Ii ◽  
Advanced Nsclc ◽  
Phase Ii Trial ◽  
Locally Advanced ◽  
Small Cell ◽  
Toxicity Profile ◽  
Small Cell Lung ◽  
Locally Advanced Nsclc

7068 Background: The treatment of choice for locally advanced non small cell lung cancer (NSCLC) is concurrent chemoradiation (CRT). However, efforts to improve treatment results include targeted therapy and the use of radiosensitizers. Nitroglycerin (NTG), a nitric oxide (NO) donor agent, reduces expression of Hypoxia-Induced Factor, which is associated to both chemo and radio resistance. Methods: This is phase II trial in patients with locally advanced NSCLC treated with chemotherapy (CT) based on cisplatin and vinorelbin with NTG concurrent with radiation therapy. A 25 mg NTG patch was administered to the patients during the first 5 days of each induction treatment cycle and during chemo-radiotherapy. Blood samples of VEGF were taken before any treatment and after two cycles of CT. The protocol is registered with ClinicalTrials.gov, number NCT00886405. Results: 35 patients were enrolled in this trial. Median Follow up was 16.6 months (SD ±13.6). Mean age was of 59.9 years (±10.8), 68.6% of the patients were smokers. ECOG status was 0 in 22.9%, 1 in 65.7% and 2 in 11.5%, respectively. Histopathology was adenocarcinoma in 68.6%, epidermoid in 17.1% and undifferentiated in 14.3%. Stage distribution was: IIIa, 57.6% and IIIb, 42.5%. All patients completed CRT treatment and four underwent surgical treatment. Toxicity profile related to NTG was grade 1 and 2 headache in 17.1%. Grade 3 and 4 toxicities were esophagitis (17.1%), neutropenia (62.9%), and nausea (5.7%). Sixty-four per cent of patients achieved partial response after CT and 75.8% after CRT. PFS was 11.8 months (95%, IC 7.8-15.6) and OS was 42.9 months (95%IC 31.3-52.1). After two cycles of CT, plasma VEGF levels were significantly lower (Median 132±79 vs. 53±78 pg/ml, p<0.001). No differences on PFS and OS were found between patients with a reduction ≥ 93 pg/ml (median of differences between VEGFR before and after chemotherapy). Conclusions: The addition of NTG to induction CT, and concurrent CRT on locally advanced NSCLC patients seems to increase the response rate, PFS and OS with an acceptable toxicity profile. A prospective trial is warranted to confirm these findings.

scholarly journals Initial Experience of Video-Assisted Thoracic Surgery Lobectomy After Neoadjuvant Chemotherapy Plus Toripalimab in a Patient with Locally Advanced Non-Small Cell Lung Cancer: A Case Report

2021 ◽  
Author(s):  
Wei Li ◽  
Chunbo Zhai ◽  
Jianpeng Che ◽  
Weiqian Wang ◽  
Bingchun Liu
Keyword(s):  
Lung Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Thoracic Surgery ◽  
Small Cell Lung Cancer ◽  
Immune Checkpoint ◽  
Advanced Nsclc ◽  
Locally Advanced ◽  
Small Cell ◽  
Small Cell Lung ◽  
Locally Advanced Nsclc

Abstract Background: Immune checkpoint inhibitors were used for patients with advanced non-small cell lung cancer (NSCLC) more and more frequently and the effects were thrilling. Toripalimab as a new immune checkpoint inhibitor has been shown to be effective in patients with advanced NSCLC. However, data regarding the safety and feasibility of surgical resection after treatment with toripalimab for NSCLC remain scarce. Here, we present a case with locally advanced NSCLC that received video-assisted thoracic surgery (VATS) lobectomy after treatment with toripalimab in combination with chemotherapy.Case presentation: A 62-year-old male patient with a history of coronary artery stenting operation for two times was found a 3.4 × 3.2cm cavity mass in the upper lobe of the left lung and enlarged left hilar and mediastinal lymph nodes. Pathological results identified squamous cell carcinoma. The patient was diagnosed with a locally advanced NSCLC and received VATS left upper lobectomy and lymph node dissection after neoadjuvant chemotherapy plus toripalimab for 3 cycles. The postoperative pathological results showed complete tumor remission. Short-term follow-up results were excellent, and long-term results remain to be revealed.Conclusions: Our preliminary results showed that the use of neoadjuvant toripalimab and chemotherapy for the locally advanced NSCLC before surgical resection is safe and feasible.

A Feasibility Study of Extended Chemotherapy for Locally Advanced Non-Small Cell Lung Cancer: A Phase II Trial of Cancer and Leukemia Group B

1994 ◽  
Vol 12 (3) ◽  
pp. 273-282 ◽  
Author(s):  
Gerald Clamon ◽  
James Herndon ◽  
Walter Eaton ◽  
Julian Rosenman ◽  
L. Herbert Maurer ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Feasibility Study ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Locally Advanced ◽  
Small Cell ◽  
Small Cell Lung ◽  
Group B ◽  
Leukemia Group

A phase II trial of S-1 plus cisplatin with concurrent proton-beam therapy for locally advanced non-small cell lung cancer.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e20070-e20070
Author(s):  
Kenji Akita ◽  
Hiromitsu Iwata ◽  
Hiroyuki Ogino ◽  
Yusuke Yamaba ◽  
Eiji Kunii ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Proton Beam ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Locally Advanced ◽  
Proton Beam Therapy ◽  
Small Cell ◽  
Small Cell Lung ◽  
Image Guided

e20070 Background: Concurrent chemo-radiotherapy is the standard treatment for locally advanced (LA) non-small cell lung cancer (NSCLC). Recent phase II studies have demonstrated that S-1 plus cisplatin (CDDP) with concurrent radiotherapy yields promising results against LA NSCLC. Proton-beam therapy (PBT) is an alternative modality that is expected to reduce toxic effects against normal tissues compared with X-ray radiotherapy. We conducted a phase II trial of S-1 plus CDDP combined with concurrent PBT for patients (pts) with LA NSCLC. Methods: The eligibility criteria included unresectable stage III NSCLC, chemo-naïve status, PS 0 or 1, and age < 75 years. Pts received CDDP (80 mg/m2) on day 1 and S-1 (30-40 mg/m2 twice daily) on days 1 to 14, q4w, up to 4 cycles, plus concurrent PBT at a total dose of 70 GyE in 35 fractions for primary lesion and 66 GyE in 33 fractions for lymph node metastasis. PBT was performed using respiratory-gated and image-guided techniques, and adaptive plans were implemented according to a verification plan at 10, 20, and 30 days. Results: Thirty-two pts were enrolled between August 2013 and December 2016. The patient characteristics were as follows: median age, 66 (31-74); male/female, 24/8; PS 0, 26 pts; stage IIIA/IIIB, 19/13; non-squamous histology, 17 (53%). Twenty pts were out of indication for radical chemo-radiation with X rays. All 4 cycles of S-1 plus CDDP could be completed in 24 pts and the median number of cycles was 3.3 (range: 2 to 4). Grade 3/4 toxicities per pt were: neutropenia 28%, anemia 13%, thrombocytopenia 9.4%, fatigue, anorexia, esophagitis, mucositis and enteritis 3.1%, and radiation pneumonitis 0%. One case of febrile neutropenia was observed. PR + CR was achieved in 24 of 28 evaluable pts. The median PFS was 12.5 months, and 2-year OS was 63%, with a median follow-up period of 19.5 (range: 1.5-40.0) months. Conclusions: Concurrent chemo-PBT using S-1 plus CDDP with image-guided and adaptive techniques is considered to be effective and well tolerated for LA NSCLC. Further evaluations in a large randomized controlled trial are warranted.

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