A phase II study of weekly docetaxel/cisplatin and concurrent radiotherapy followed by surgery in patients with stage III non-small cell lung cancer (NSCLC)

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 18050-18050
Author(s):  
K. W. Maas ◽  
E. C. Phernambucq ◽  
S. Y. Sharouni ◽  
J. A. Stigt ◽  
H. J. Groen ◽  
...  
Keyword(s):  
Phase Ii ◽  
Malignant Disease ◽  
Phase Ii Study ◽  
Radical Resection ◽  
Stage Iiib ◽  
Stage Iii ◽  
Induction Treatment ◽  
Stage Iiia ◽  
Weekly Docetaxel ◽  
Stage Iii Nsclc

18050 Background: Concurrent chemoradiotherapy treatment is standard of care for patients with stage III NSCLC in good performance. Optimal chemotherapy have yet to be defined and the role of surgery is still unclear. This prospective phase II study analysed the feasibility and efficacy of weekly docetaxel/cisplatin (DC) and concurrent involved-field thoracic radiotherapy (CRT) followed by surgery in good performance status patients with stage IIIA/B NSCLC. Primary endpoint is radiological response of DC and CRT. Secondary endpoints included toxicity, efficacy of surgery, postoperative morbidity and mortality, time to progression and overall survival. Methods: DC consisted of IV docetaxel 20 mg/m2 and cisplatin 20mg/m2 at days 1,8,15,22,29 and 36. CRT was given in once-daily fractions of 1.8 Gy, 5 fractions a week to a total dose of 45 Gy during days 8 to 36. CT-based planning was used to minimise radiation to the contralateral lung. Invasive and non-invasive investigations were performed after induction treatment in order to restage the mediastinum. when mediastinal downstaging was achieved, surgery was performed in order to achieve radical resection. Results: Between January 2005 until August 2006, 45 patients were included, of whom 43 patients were evaluable. Stage IIIB disease was present in 18 patients (cT4N2=9, cT4N0/N1=5 and cN3=4) and 25 had stage IIIA-N2 disease. Radiologic response was seen in 20 patients (47%) and 8 (19%) showed progressive disease. Toxicity was mild. Explorative thoracotomy was performed in 24 (56%) patients. Of these, 14 were initially staged as IIIA and ten as stage IIIB (4 of whom had N3 metastases). Twenty patients (47%) underwent a radical resection without residual mediastinal malignant disease, and ten pneumonectomies (8 left sided) were performed. Three patients showed complete pathological response. The 30 days mortality after operation was 4% (one patient) due to ARDS. Conclusions: Weekly DC and CRT is possible in stage III NSCLC, with limited toxicity and nearly half of the treated patients (47%) could undergo a radical surgical resection (R0) without residual mediastinal malignant disease. This promising tri-modality regimen should be tested in future phase II or III trials. No significant financial relationships to disclose.

Erlotinib as maintenance therapy after concurrent chemoradiotherapy in patients (p) with stage III non-small cell lung cancer (NSCLC): A Galician Lung Cancer Group phase II study

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 7537-7537
Author(s):  
J. Casal ◽  
S. Vázquez ◽  
L. León ◽  
M. Lázaro ◽  
J. L. Fírvida ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Squamous Cell Carcinoma ◽  
Maintenance Therapy ◽  
Cell Carcinoma ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Stage Iii ◽  
Stage Iiia ◽  
Unresectable Stage ◽  
Stage Iii Nsclc

7537 Background: Combination of platinum-based chemotherapy and radiotherapy is the standard treatment for p with unresectable stage III NSCLC, but considering the high rates of recurrence, it is necessary to improve these results. Erlotinib is an EGFR TKI that prolongs survival in p with recurrent and metastatic NSCLC. In this study, we aim to evaluate the role of erlotinib as maintenance therapy after a standard concurrent chemo-radiotherapy regimen in p with stage III NSCLC. Methods: P with unresectable stage IIIA/IIIB—without malignant effusions—NSCLC who had received a standard concurrent chemo-radiotherapy regimen and had no evidence of tumor progression were enrolled in this single arm, open-label phase II study and received erlotinib 150 mg/day po for 6 months. Main eligibility criteria were: PS 0–2, adequate bone marrow, hepatic and renal function and measurable disease by RECIST criteria. Primary endpoint was the percentage of p without evidence of disease progression after 6 months of erlotinib therapy and secondary endpoints were: PFS, OS, ORR and safety profile. Results: 49 p have been included in the study and data from 37 p are presented in this analysis. Baseline characteristics: median age 62 years (range 41–76); male 94.6%; caucasian 100%; smokers/never smokers (%) 97.3/2.7; ECOG PS 0/1/2 (%) 18.9/75.7/2.7; adenocarcinoma/squamous cell carcinoma/large cell carcinoma (%) 16.2/75.7/5.4; stage IIIA/IIIB (%) 16.2/83.8. Most common previous chemo-radiotherapy regimen is cisplatin/docetaxel/RT (83.8%). 27 p were evaluable for tumor response: CR 22.2%; PR 12.8%; SD 55.6%; PD 7.4%. Median TTP was 7.3 months (95% CI 5.8–16.9) and median OS was 18.7 months (95% CI 11.8-NA). Most common adverse events related to erlotinib were rash 30.6% (3 p gr. 3) and diarrhea 16.7%. Conclusions: Erlotinib as maintenance therapy is an active and well tolerated treatment after concurrent chemo- radiotherapy in p with stage III NSCLC. In spite of the majority of patients are caucasian, males, smokers with squamous cell carcinoma, maintenance with single agent erlotinib reached a promising median OS of 18.7 months. Updated data will be presented. No significant financial relationships to disclose.

Phase II study of TS-1 (S) plus cisplatin (P) with concurrent thoracic radiotherapy for unresectable stage III non-small cell lung cancer (NSCLC)

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 18070-18070
Author(s):  
F. Ohyanagi ◽  
N. Yamamoto ◽  
A. Horiike ◽  
T. Horai ◽  
K. Gomi ◽  
...  
Keyword(s):  
Phase Ii ◽  
Response Rate ◽  
Phase Ii Study ◽  
Performance Status ◽  
Progression Free Survival ◽  
Stage Iii ◽  
Fourth Generation ◽  
Unresectable Stage ◽  
Stage Iii Nsclc ◽  
Grade 3

18070 Background: Although combined chemoradiotherapy is the standard of care in stage III NSCLC, the optimal chemotherapy regimen is not established. S-1, a fourth-generation oral fluoropyrimidine is an active new agent for NSCLC and the combination with cisplatin has a favorable toxicity profile. The objective of this study was to evaluate feasibility and efficacy of S plus P with concurrent radiation for unresectable stage III NSCLC. Methods: Patients with histologically or cytologically confirmed NSCLC, 20 to 75 years in age, performance status 0–1, with no prior chemotherapy were eligible for the study. Patients were treated with P (60 mg/m2 on day 1) and S (orally at 40 mg/m2/dose bid (80 mg/m2/d), on days 1 to 14) repeated every 3–4 weeks for 4 cycles and TRT (60 Gy/30 fr over 6 weeks starting on day 2). The primary endpoint was the response rate (RR), and planned sample size for this phase II study was 28 patients (Simon’s two-stage minimax design, P0=70%, P1=90%, a =0.1, β = 0.1). Results: Of 28 patients enrolled between August 2005 and October 2006, 28 were evaluable. There were 24 males and 4 females, median age of 63 (range 40–74) and 11 IIIA and 17 IIIB. Chemoradiotherapy was well tolerated; 2 cycles of SP and 60 Gy of TRT were administered in all patients and 24 (86%) patients received 4 cycles of SP. During concurrent chemoradiotherapy, grade 3 toxicities were neutropenia (8 pts), leukopenia (6 pts), fatigue (6 pts), anorexia (5 pts), febrile neutropenia (4 pts) and, esophagitis (4 pts). Only one grade 4 leukopenia were observed. During consolidation therapy, grade 3–4 neutropenia, anemia, esophagitis, and pneumonitis were developed in 4, 1, 1 and 2 patients, respectively. No toxic deaths have occurred. Overall RR was 85.7% (95% CI: 79.1- 98.7%) with 4 SDs and 24 PRs. The median progression-free survival and median survival is not mature enough to estimate as only 4 progression and no deaths have occurred. Conclusions: This chemoradiotherapy regimen produced promising response rate in patients with stage III NSCLC and it seems to be well-tolerated. No significant financial relationships to disclose.

Cisplatin and docetaxel plus concurrent three-dimensional (3D) conformal radiotherapy in unresectable stage III A/B NSCLC

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e18503-e18503
Author(s):  
L. Arcangeli ◽  
B. Orlandini ◽  
M. Torre ◽  
C. Carbonini ◽  
A. Sbarufatti ◽  
...  
Keyword(s):  
Performance Status ◽  
Conformal Radiotherapy ◽  
Stage Iiib ◽  
Stage Iii ◽  
Stage Iiia ◽  
Weekly Docetaxel ◽  
Unresectable Stage ◽  
Platinum Based Chemotherapy ◽  
Thoracic Radiation ◽  
Stage Iii A

e18503 Background: Concurrent chemoradiation is standard of care for most patients with unresectable stage III A/B NSCLC but no standard chemotherapy regimen/schedule has been established. We conducted an experience to evaluate the efficacy and toxicity of a combination consisting of weekly docetaxel/cisplatin and radiotherapy in patients with unresectable stage III A/B NSCLC. Methods: Unresectable stage III A/B NSCLC pts with a good performance status (ECOG PS 0–1) were eligible. Patients with stage IIIB were chemonaive, while patients with stage IIIA were inoperable after a first line platinum-based chemotherapy. Treatment consisted of docetaxel 25 mg/m2 IV infusion followed by cisplatin 25 mg/m2 IV infusion was administered weekly during concurrent thoracic radiotherapy. Concurrent 3D-conformal RT thoracic radiation consisted of 45 Gy (1.8 Gy fractions 5 days/wk for first five weeks. Results: From 2006/01 to 2008/04, 16 pts were enrolled and all were evaluable for toxicity and response. Pt. characteristics: median age- 68 years (54–77), 80% males. Nine pts had stage IIIA (56%) and 7 patients had stage IIIB (44%).Histology subtypes included epidermoid (25%) and adenocarcinoma (75%). Radiologic response was seen in 11 patients (68%). Four patients had a stable disease (25%). Disease progression has occurred in 1 pt. Six patients undergone surgery after chemo-radiotherapy (37%). Four patients (25%) underwent a radical resection without residual mediastinal malignant disease. Toxicity was mild. Conclusions: Weekly docetaxel/cisplatin with concurrent 3D-conformal RT thoracic radiation plus is a well-tolerated out-patient regimen. and is feasible by multi-physicians collaboration group. No significant financial relationships to disclose.

Stage III non small lung cancer (NSCLC): Docetaxel (D), gemcitabine (G), and cisplatin (C) as induction chemotherapy, an Italian phase I study

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 18201-18201
Author(s):  
S. De Santis ◽  
V. Donato ◽  
M. R. Migliorino ◽  
B. Tedesco ◽  
S. Condo ◽  
...  
Keyword(s):  
Phase I ◽  
Induction Chemotherapy ◽  
Phase Ii ◽  
Phase I Study ◽  
Objective Response ◽  
Stage Iii ◽  
Stage Iiia ◽  
Phase Ii Studies ◽  
Stage Iii Nsclc ◽  
Grade 3

18201 Background: Based on the several clinical trials, combined modality therapy became the standard of care for patients with stage III NSCLC “unresectable” with good performance status (Kathy S. Albain, Educational Book ASCO 2006, 453–461; Thomas E. Stinchcombe, Oncologist 2006, 11, 809–823). The most effective induction chemotherapy has yet to be determined. The objective of this prospective phase I study was to define the maximum tolerated dose (MTD), and to evaluate the activity and safety of one of the third generation triplets as a full dose neoadjuvant regimen in patients (pts) with unresectable Stage III NSCLC. Methods: In this study, chemotherapy-naïve pts with stage IIIA-N2 bulky and IIIB (except malignant pleural effusion) NSCLC were eligible. Inclusion into the trial and treatment decisions were done by multidisciplinary panel involving surgeons, medical oncologists and radiotherapists. All drugs were given intravenously on days 1 and 8, and repeated every 3 weeks up to 2 cycles followed by concurrent chemoradiation. D (30–35 mg/m2) was given first, followed by C (35 mg/m2) and G (1000 mg/m2). Results: From Jan ‘06 to Jul ‘06 twelve eligible pts were enrolled, 10/2 m/f gender; median age 63 (50–72), 1 patient with ECOG PS 0, 11 pts with PS 1; 5 pts with stage IIIA-N2 bulky, 7 pts with stage IIIB NSCLC; nine pts were smokers. All pts were evaluable for toxicity. Toxicity grade 3–4 by CTC criteria was: grade 3 neutropenia in 2/3 patients and grade 3 thrombocytopenia in 1/3 patients on the second dose level of chemotherapy (i.e. docetaxel 35 mg/m2), and was considered dose-limiting. Of 9 pts treated at the MTD (i.e. docetaxel 30 mg/m2), only 1 patient developed grade 4 neutropenia and 1 patient grade 3 thrombocytopenia; 3 patients (30%) had grade 2 neutropenia and grade 2 stomatitis. Of 12 evaluable pts for response, after induction chemotherapy eighty-three percent of patients (9/12 pts) had an objective response and 16,6% (2/9 pts) stable disease. Phase II is continuing for larger patient accrual. Conclusions: The recommended doses for further phase II studies are D (30 mg/m2) followed by C (35 mg/m2) and G (1000 mg/m2) every 3 weeks. This regimen is well tolerated and effective, and appears to be an excellent choice for stage III NSCLC. No significant financial relationships to disclose.

Phase II study of weekly docetaxel plus cisplatin as first-line therapy in advanced or metastatic non-small cell lung cancer (CHN TAX-206)

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 18173-18173
Author(s):  
D. Chu ◽  
J. Li ◽  
X. Zhang ◽  
J. Liu ◽  
Z. Chen ◽  
...  
Keyword(s):  
Phase Ii ◽  
Phase Ii Study ◽  
Complete Response ◽  
Median Number ◽  
Common Adverse Event ◽  
Stage Iiib ◽  
Hematologic Toxicity ◽  
First Line ◽  
Weekly Administration ◽  
Weekly Docetaxel

18173 Background: There has been increasing interest in the use of weekly administration of docetaxel as a way of reducing its hemotologic toxicity. Weekly docetaxel plus cisplatin has also shown promising efficacy and well tolerability for first-line treatment of advanced or metastatic NSCLC in our previous phase I study (2002 ASCO, abstract No 2744). We conducted this phase II trial to further evaluate this regimen’s efficacy and toxicity. Methods: Patients with histologically confirmed stage IIIB or IV NSCLC were treated with docetaxel (35 mg/m2, 30 min. iv. infusion) on days 1, 8, 15 and cisplatin (75 mg/m2, 30 min. iv. infusion) on day 1 repeated every 4 weeks for up to 6 cycles. Pts received oral dexamethasone 7.5 mg twice daily from the day before chemotherapy and consecutive two days thereafter. The primary endpoint of this phase II study is efficacy of the regimen. Results: A total of 83 patients were enrolled from July 2002 to June 2004, 75 patients were evaluable for response and 83 for safety. Median age was 55 years (range 29–70 years); and 69.9% were male; adenocarcinoma/squamous cell carcinoma/others (65/12/6); stage IIIB /IV( 47/36); ECOG PS 0/1(52/31). Median number of chemotherapy cycles was 3(1–5). One CR (complete response) and 22 PR (partial response) were achieved with an ORR of 30.7% in the evaluable patients. The 1-year survival was 48.6% with a median survival of 10.7 months (range: 3–34 months). Neutropenia was the most common adverse event, though most were mild; Grade III/IV toxicities per patient were: Neutropenia (15.6%), asthenia (11%), skin/nail toxicity (10.8%) and vomiting (9.6%). Febrile neutropenia was not observed. Conclusions: In the present study, the combination of weekly administration docetaxel combining with cisplatin appears well tolerated with very low frequency of severe hematologic toxicity and similarly efficacious as 3-weekly docetaxel in NSCLC pts. No significant financial relationships to disclose.

Maintenance gefitinib (G) after chemoradiotherapy (CRT) in patients (pts) with unresectable stage IIIA/B non-small cell lung cancer (NSCLC): A phase II trial of the Minnie Pearl Cancer Research Network

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 7188-7188
Author(s):  
J. R. Gray ◽  
D. R. Spigel ◽  
J. D. Hainsworth ◽  
E. Vazquez ◽  
J. D. Peyton ◽  
...  
Keyword(s):  
Phase Ii ◽  
Phase Ii Trial ◽  
Progression Free Survival ◽  
Large Cell ◽  
Research Network ◽  
Stage Iii ◽  
Stage Iiia ◽  
Unresectable Stage ◽  
Stage Iii Nsclc ◽  
Ecog Ps

7188 Background: Concurrent CRT improves outcomes for pts with unresectable stage III NSCLC compared with radiation (RT) alone. The EGFR inhibitor G benefits select pts with advanced NSCLC. This multicenter community phase II trial examined the role of CRT followed by G for pts with unresectable stage III NSCLC. Methods: Theprimary endpoint was 2-year overall survival (OS) in pts with unresectable stage IIIA/B NSCLC (effusions, N3 mediastinal nodes >4 cm excluded) treated with CRT followed by G. Induction(I) treatment (tx): docetaxel (D) 40 mg/m2 IV and gemcitabine 800 mg/m2 IV D1, 8 Q 21D × 3 cycles. Pts without progressive disease (PD) began: D 20 mg/m2 IV and carboplatin (C) AUC = 1.5 IV weekly × 6 and RT 61.2 Gy, 1.8-Gy M-F weekly × 7 (starting 1 week prior to D/C). If no PD, pts received G 250 mg PO daily × 2 years or until PD. Eligibility:measurable disease, ECOG PS 0–1, informed consent. Intent to treat analysis. Results: One-hundred three pts were enrolled from 7/03 to 4/05. Baseline features: medianage 60 years (37–79); male/female 54%/46%; ECOG PS 0/1:26%/74%; adenocarcinoma (26%), squamous (32%), large cell (28%), mixed/not specified (14%); IIIA/B (46%/54%). Grade 3/4 toxicities were limited to ≤ 8% except for neutropenia (17%, during I) - with notx-related deaths. Complete/partial responses after I were seen in 1 pt/34 pts, respectively, for an overall response rate (RR) of 34% (95% CI 26%-44%). Forty-two pts (41%) had stable disease (SD) and 12% had PD (9 pts were unevaluable.) Seventy-four pts (72%) received D/C/RT which resulted in an overall RR of 44% (95% CI 35%-54%). Fifteen percent had SD. Fifty-six pts (54%) received G for a median of 28 weeks (1–107). Median PFS and OS are 9.9 and 15 months, respectively. After a median follow-up of 19 months, actuarial 1- and 2-year progression-free survival (PFS) is 41% and 12%, respectively. 1- and 2-year OS rates are 64% and 21%, respectively. Subset analyses by smoking, gender, histology, and stage are in progress. Conclusions: Maintenance G following CRT in unresectable NSCLC does not appear to improve survival. It is possible that further analysis may suggest a role for G in selected pts. [Table: see text]

Stage III NSCLC: How many patients are really suitable for radical treatment approaches?

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e17532-e17532
Author(s):  
Humaid Obaid Al-Shamsi ◽  
Peter Michael Ellis
Keyword(s):  
Clinical Trials ◽  
Stage Iiib ◽  
Stage Iii ◽  
Published Data ◽  
Stage Iiia ◽  
Eligibility Criteria ◽  
Treatment Approaches ◽  
Radical Treatment ◽  
Stage Iii Nsclc ◽  
Nsclc Patients

e17532 Background: Stage III NSCLC represents a heterogeneous population. Patients with good performance status (PS) and weight loss < 10% (WL<10) are generally considered for radical treatment with chemoradiation or trimodality approaches. Outcome data from Cancer Care Ontario show 30% of stage III NSCLC (6th edition TNM) patients receive chemoradiation.There is significant variation between local health networks. We examined the proportion of patients with stage III NSCLC suitable for radical treatment. Methods: We conducted a retrospective cohort study of patients diagnosed with stage III NSCLC at the Juravinski Cancer Center from July 2007 to June 2009. Demographic, pathologic and treatment data were abstracted from patients’ records. The primary outcome was the proportion of stage III NSCLC patients eligible for radical treatment. We also compared patients treated radically versus palliatively. Results: 159 stage III NSCLC patients (staged by 6th edition TNM) were seen. The median age was 69 yrs (sd 12) with 58% men and 42% women. There were 40% stage IIIA, 37% IIIB and 23% IIIB (wet). 61 (38%) patients were treated with radical intent and 98 (62%) were treated palliatively. Reasons for palliative treatment approach were WL >10% (7%), PS >2 (10% ), both WL >10% and PS >2 (20%), significant comorbidities (9%),patient declined (9%) and stage IIIB wet(23 %).The median OS for patients treated radically was 23.3 months v 7.1 months for those treated palliatively. Stage IIIA patients treated radically had better OS than IIIB (27m v 14m). Patients with poor PS, or WL>10% had similar OS to patients with wet stage IIIB (7.1m v 7.2m), whereas the survival of patients with poor PS and WL >10% was worse (3m). Conclusions: Using eligibility criteria from clinical trials of stage III NSCLC, only 40% of patients appear eligible for radical treatment approaches. Our data are consistent with published data. Significant WL>10% or poor PS (>2) predicted poor outcome. Combined WL>10% and poor PS predicted a very poor prognostic group. Criteria for radical treatment of stage III NSCLC should not be extrapolated beyond the eligibility criteria used in clinical trials.

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