A phase II study of intravenous (IV) milataxel (M) for the treatment of non-small cell lung cancer (NSCLC) refractory to platinum-based therapy

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 7098-7098 ◽  
Author(s):  
T. Mekhail ◽  
P. Serwatowski ◽  
A. Dudek ◽  
C. Belani ◽  
R. Jankowska ◽  
...  
Keyword(s):  
Adverse Events ◽  
Response Rate ◽  
Performance Status ◽  
Objective Response ◽  
Locally Advanced ◽  
Median Number ◽  
Open Label ◽  
Heavily Pretreated ◽  
Grade 3 ◽  
Number Of Cycles

7098 Background: M (TL139, MAC-321) is a novel taxane that has shown activity when administered IV or orally in both taxane-resistant and susceptible nude mouse xenograft models. The current study is an open-label study in previously treated patients (pts) with locally advanced, metastatic, or recurrent NSCLC to determine response rate. Methods: Pts with cytologically or histologically confirmed NSCLC must have received 1 or 2 prior regimens including prior platinum, and may have received prior paclitaxel or docetaxel. Good performance status (ECOG 0 or 1), and adequate hematologic, hepatic and renal function were required. Pts with clinically active brain metastases were excluded. Pts were treated with M 35 mg/m2 as a 4 hr IV infusion every 3 weeks. The primary end point was objective response rate. Results: A total of 46 pts were treated: 21 (46%) female pts and 25 (54%) male pts. Mean age was 59 (range 41–85), ECOG was PS 0 in 13 (28%) pts, PS 1 in 31 (67%) pts and unknown in 2 (4%) pts. The number of prior chemotherapy regimens was > 1 in 21 (46%) pts. Twenty-five (54%) pts had one prior taxane and 7 (15%) pts had both paclitaxel and docetaxel previously. The median number of cycles was 3 (range 1–14). Nine (20%) pts required dose reduction. Five (11%) pts discontinued treatment due to adverse events. A total of 25 (54%) pts reported drug related grade 3 or 4 adverse events. Non-hematologic grade 3 or 4 drug-related events occurring in more than 1 pt included: neuropathy 4 (9%) pts, neutropenic fever 3 (7%) pts, arthralgia 2 (4%) pts. There was no treatment related mortality. Objective responses were confirmed in 4 (9%) pts (3 PR, 1 CR). Three pts with response (including pt with CR) had received prior docetaxel. PR duration was 175, 250, and 315 days. Pt with CR received 4 cycles of M and discontinued due to the CR. Pt remained in CR at day 504. Conclusions: Milataxel 35 mg/m2 as a 4 hr IV infusion every 3 weeks provided durable responses in heavily pretreated pts including pts who had previously received taxanes. No significant financial relationships to disclose.

Efficacy and Safety of Denileukin Diftitox (Ontak®) in the Treatment of Cutaneous T-Cell Lymphoma (CTCL) According to CD25 Status.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 2712-2712 ◽  
Author(s):  
Francine Foss ◽  
Madeleine Duvic ◽  
Larisa Geskin ◽  
Joseph Anderson ◽  
Pierluigi Porcu ◽  
...  
Keyword(s):  
Response Rate ◽  
Interleukin 2 ◽  
Median Number ◽  
Open Label ◽  
Denileukin Diftitox ◽  
Common Grade ◽  
Stage Ivb ◽  
Grade 3 ◽  
Number Of Cycles ◽  
Multi Center Study

Abstract Denileukin diftitox, an interleukin-2 (IL-2)-diphtheria toxin fusion protein, binds to and intoxicates cells expressing the medium (CD122, CD132) and high affinity (CD25, CD122, CD132) IL-2 receptor. Because its role in patients whose tumors tested negative for the CD25 component of the receptor had not been prospectively studied, we initiated a prospective, open label, multi-center study to evaluate the safety and efficacy of denileukin diftitox in CTCL patients according to CD25 status (CD25+ and CD25-). Patients with pathologically proven, persistent or recurrent CTCL Stages IB-IVA were treated with denileukin diftitox at a dose of 18 mcg/kg/day x 5 days every 21 days for up to 8 cycles. Expression of CD25 by tumor cells in skin biopsies was determined by IHC or flow cytometry at a central laboratory and investigators were blinded to CD25 status. Response was based on improvement in skin involvement by weighted skin assessment for lesion type (patch, plaque, tumor) and blood involvement based on quantitation of Sezary cells. Safety was evaluated based on reports of Grade 3 and 4 toxicities (NCI CTC version 2.0). Sixty-one pts were enrolled and treated with denileukin diftitox. Disease stages were: I-IIA (n=14), IIB (n=22), III (n=11) and IV (n=14). Eighteen (29.5%) had blood involvement. Fifty-seven pts completed at least one cycle of treatment and were evaluable for response. Four pts were excluded because they had Stage IVB (visceral) disease (n=2), did not have a post baseline skin assessment recorded (n=1), or did not complete the first cycle (n=1). The median number of cycles of denileukin diftitox was 4 (range 1–13). The overall response rate (CR+PR) was 53% (30/57, 95% CI 40–66%), with 2 CR. Of the 57 evaluable pts, tumor was CD25+ in 34 (70%), CD25- in 14 (25%) and unknown in 9. Response rate was similar in patients whose tumor tested CD25+ (56%, 95% CI: 39–73%), and CD25- (43%, 95% CI: 17–69%) (p=0.41). For the 61 patients the most common grade 3/4 toxicities included constitutional symptoms (11%) and metabolic/laboratory abnormalities (36%). One patient with significant cardiopulmonary disease died of myocardial infarction while on therapy. The frequency of grade 3/4 toxicities was similar in CD25+ 64% (23/36), vs CD25- 75% (12/16) (p=0.62). In conclusion, we found that 70% of the CTCL pts evaluated for this study tested CD25+ and that the response rates and safety profile of denileukin diftitox in CD25+ and CD25- patients were similar. These data support a role for denileukin diftitox in the treatment of CTCL regardless of CD25 status.

Phase II Trial of Irinotecan in Children With Relapsed or Refractory Rhabdomyosarcoma: A Joint Study of the French Society of Pediatric Oncology and the United Kingdom Children's Cancer Study Group

2007 ◽  
Vol 25 (4) ◽  
pp. 356-361 ◽  
Author(s):  
Gilles Vassal ◽  
Dominique Couanet ◽  
Elizabeth Stockdale ◽  
Anne Geoffray ◽  
Birgit Geoerger ◽  
...  
Keyword(s):  
Phase Ii ◽  
Response Rate ◽  
Single Agent ◽  
Objective Response ◽  
Median Number ◽  
Tumor Burden ◽  
French Society ◽  
Heavily Pretreated ◽  
Grade 3 ◽  
Multiagent Chemotherapy

PurposeThis phase II study was designed to evaluate the efficacy of irinotecan administered intravenously once every 3 weeks in pediatric patients with recurrent or refractory rhabdomyosarcoma.Patients and MethodsA total of 35 patients younger than age 20 years, with refractory or relapsed rhabdomyosarcoma for which standard treatments have failed, received irinotecan at 600 mg/m2administered as a 60-minute infusion every 3 weeks. Concomitant treatments included atropine for cholinergic symptoms, loperamide for diarrhea at the first liquid stool, and preventive antiemetic treatment. Tumor response was assessed every two cycles until progression according to WHO criteria.ResultsThe best overall response rate to irinotecan was 11.4% (95% CI, 3.2 to 26.7%; 2.9% complete responses, 8.5% partial responses) from all patients recruited. The median times to progression and survival were 1.4 and 5.8 months, respectively. A total of 112 cycles were administered, with a median number of two cycles per patient (range, 1 to 16). The most common grade 3/4 toxicities were neutropenia (46%), abdominal pain or cramping (17%), cholinergic syndrome (14%), nausea/vomiting (11%), anemia (11%), thrombocytopenia (9%), and diarrhea (6%).ConclusionIn heavily pretreated children with a high tumor burden who have been treated with multiagent chemotherapy, irinotecan administered intravenously as a single agent, at 600 mg/m2every 3 weeks, showed an interesting objective response rate and a good tolerance profile in rhabdomyosarcoma.

Cetuximab, paclitaxel, cisplatin and concurrent radiation in Chinese patients with locally advanced esophageal squamous cell carcinoma: An open-label, multicenter, phase II study.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 4073-4073
Author(s):  
Jinming Yu ◽  
Xue Meng ◽  
Jian hua Wang ◽  
Xindong Sun ◽  
Lv hua Wang ◽  
...  
Keyword(s):  
Squamous Cell Carcinoma ◽  
Adverse Events ◽  
Cell Carcinoma ◽  
Phase Ii ◽  
Squamous Cell ◽  
Response Rate ◽  
Locally Advanced ◽  
Chinese Patients ◽  
Open Label ◽  
Grade 3

4073 Background: In China more than 90% of esophageal malignancies are of squamous cell carcinoma (SCC). We conducted this Chinese multicenter trial to determine the efficacy and safety of the addition of cetuximab with paclitaxel, cisplatin, and concurrent radiation for patients with esophageal SCC and to determine whether KRAS status predicts response. Methods: Patients with unresectable locally advanced cervical, upper or mid-esophageal SCC without distant metastasis were eligible for this open-label phase II trial. All patients received cetuximab (400 mg/m2 day 1 before chemoradiotherapy and 250 mg/m2 q1w × 7 weeks), paclitaxel (45 mg/m2 q1w × 7 weeks) and cisplatin (20 mg/m2 q1w × 7 weeks) with 59.4 Gy of radiation. The primary end point was response rate. Second end points included toxicity, overall survival (OS), progression-free survival (PFS), and KRAS mutation status. Results: Fifty-five patients were enrolled and evaluable to safety. Non-hematological adverse events were generally grade 1 or 2, and were most often rash (94.5%), mucositis (58.2%), fatigue (45.5%), nausea (41.8%) and hepatic dyfunction (40%). Hematologic adverse events included grade 3 neutropenia (32.7%) and grade 3 anemia (1.82%). Ten patients did not complete the protocol therapy (6 for chemotherapy dose delays, 1 for paciltaxel hypersensitivity, 1 by the treating physicians for unstated reasons, 1 for concurrent unrelated infection, and 1 for tracheo-esophageal fistula). The response rate was 97.7%. The 1-year OS and median OS was 87.3% and 16.8 months, the 1-year PFS and median PFS was 30.4% and 13.9 months, respectively. No mutations were detected at KRAS codons 12 or 13 in the 52 available specimens. Conclusions: Cetuximab can be safely administered with chemoradiation for Chinese patients with esophageal cancer and may improve the clinical response rate. KRAS mutations were too rare to be analyzed as a predictor of response.

Cougar-02: A randomized phase III study of docetaxel versus active symptom control in patients with relapsed esophago-gastric adenocarcinoma.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 4023-4023 ◽  
Author(s):  
Natalie Cook ◽  
Andrea Marshall ◽  
Jane M. Blazeby ◽  
John A. Bridgewater ◽  
Jonathan Wadsley ◽  
...  
Keyword(s):  
Gastric Adenocarcinoma ◽  
Performance Status ◽  
Symptom Control ◽  
Objective Response ◽  
Locally Advanced ◽  
Median Number ◽  
Phase Iii ◽  
First Line ◽  
Open Label ◽  
Line Chemotherapy

4023 Background: Survival in patients who relapse after first-line chemotherapy (CT) for advanced esophago-gastric adenocarcinoma (EGC) is poor though recently randomised trials (RCT) have suggested a small benefit for second line chemotherapy with taxanes or irinotecan. There is very little data on health related quality of life (HRQL) or overall survival (OS), particularly in patients who progress shortly after first-line therapy. Methods: COUGAR-02 was a multicentre open-label, phase III RCT for patients with locally advanced or metastatic EGC of performance status (PS) 0-2 who had progressed within 6 months of previous platinum/fluoropyrimidine CT. Patients were randomised (1:1) to receive either docetaxel 75mg/m2every 3 weeks for up to 6 cycles or active symptom control (ASC). The primary endpoint was OS. The secondary endpoint of HRQL, assessed using EORTC QLQ-C30 and QLQ-ST022, was analysed using standardised area under a curve and compared using Wilcoxon rank sum test. Sensitivity analysis adjusting for dropouts due to death were performed using quality adjusted survival. Results: 168 patients (84 patients in each arm) were recruited between April 2008 and April 2012. Median age was 65 years (range 28-84); 81% were males. PS at randomisation was 0 for 27%, 1 for 57% and 2 for 15%. 86% had metastatic disease. 43% progressed during previous CT, 28% progressed within 3 months of end of previous CT and 29% progressed between 3 and 6 months. Median number of cycles of docetaxel was 3. 23% completed 6 cycles. Docetaxel was well tolerated and resulted in a significantly improved OS over ASC alone (HR=0.67 (95% CI 0.49-0.92); p=0.01). Objective response rate was 7%. For QLQ-C30, patients on docetaxel arm reported significantly less pain (p=0.0008) and trend for less nausea and vomiting (p=0.02) and constipation (p=0.02) than those on ASC arm. Similar global HRQL seen (p=0.53).For QLQ-ST022, trend seen for less dysphagia (p=0.02) and pain symptoms (p=0.01) for patients on docetaxel arm than ASC Conclusions: Docetaxel provided a significant OS benefit over ASC with improvements in symptom scores and no loss in overall HRQL. Docetaxel can be considered a standard of care in this setting. Clinical trial information: NCT00978549.

Phase III randomized trial of chemotherapy with or without bevacizumab (B) in patients (pts) with recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN): Survival analysis of E1305, an ECOG-ACRIN Cancer Research Group trial.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 6000-6000 ◽  
Author(s):  
Athanassios Argiris ◽  
Shuli Li ◽  
Panayiotis Savvides ◽  
James Ohr ◽  
Jill Gilbert ◽  
...  
Keyword(s):  
Response Rate ◽  
Performance Status ◽  
Objective Response ◽  
Locally Advanced ◽  
Phase Iii ◽  
Improved Outcomes ◽  
History Of ◽  
Grade 3 ◽  
Bleeding History ◽  
Platinum Doublet

6000 Background: The addition of B, an anti-VEGF monoclonal antibody, to chemotherapy has improved outcomes in several solid tumors. Pemetrexed plus B showed promising efficacy in R/M SCCHN (Argiris et al. JCO 2011). E1305 was designed to evaluate the addition of B to a platinum doublet in R/M SCCHN. Methods: B-eligible pts with performance status 0-1, not having received chemotherapy for R/M SCCHN (prior chemotherapy for locally advanced disease allowed ≥ 4 months) and without factors predisposing to bleeding (history of bleeding due to SCCHN, anticoagulation, central cavitary lung metastasis, carotid invasion) were randomized to: A) one of 4 regimens (investigator's choice) given every 3 weeks: A1, cisplatin (C) 100 mg/m2, 5-FU 1000 mg/m2/day x 4 days; A2, carboplatin (Cb) AUC 6, 5-FU 1000 mg/m2/day x 4 days; A3, C 75 mg/m2, docetaxel (D) 75 mg/m2; A4, Cb AUC 6, D 75 mg/m2, or B) the same regimen (B1, B2, B3, B4) plus B 15 mg/Kg IV, every 3 weeks, until progression. Chemotherapy could be stopped after 6 cycles after maximum response. All pts received prophylactic antibiotics. The primary endpoint was overall survival (OS). Control median OS of 8.5 months (mo) was projected; the addition of B was hypothesized to increase median OS to 11.5 mo with a hazard ratio (HR) of 0.74. Results: 403 pts were randomized (200 in arm A; 203 in arm B). Baseline characteristics were well balanced. 38% in arm A/42% in arm B had an oropharyngeal primary; 87% received C or Cb plus D. With a median follow-up of 23.1 mo, median OS was 11 mo in arm A and 12.6 mo in arm B; HR 0.84 (95% CI 0.67-1.05), p = 0.13. The 1-, 2-, 3-, and 4-year OS were 46% vs 51%, 18% vs 26%, 8% vs 16%, 6% vs 13%, in arm A vs B, respectively. Median PFS was 4.4 mo in arm A and 6.1 mo in arm B (HR 0.71, 95% CI 0.58-0.87; p = 0.0012). Objective response rate was 25% in arm A vs 36% in arm B (p = 0.013). Grade 3-5 bleeding occurred in 3.5% in arm A vs 7.7% in arm B (p = 0.08). Conclusions: B added to a standard platinum doublet improved response rate and PFS but not OS in first-line treatment of R/M SCCHN. The control arm in this study performed better than expected. Clinical trial information: NCT00588770.

Phase II study of eribulin mesylate (E7389), a mechanistically novel inhibitor of microtubule dynamics, in patients with advanced non-small cell lung cancer (NSCLC)

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 7546-7546 ◽  
Author(s):  
A. I. Spira ◽  
N. O. Iannotti ◽  
M. A. Savin ◽  
M. Neubauer ◽  
N. Y. Gabrail ◽  
...  
Keyword(s):  
Phase Ii ◽  
Response Rate ◽  
Phase Ii Study ◽  
Objective Response ◽  
Median Number ◽  
Microtubule Dynamics ◽  
Synthetic Analog ◽  
Open Label ◽  
Eribulin Mesylate ◽  
Grade 3

7546 Background: Eribulin is a structurally-simplified, fully synthetic analog of the marine sponge natural product halichondrin B. Eribulin inhibits microtubule dynamics via a mechanistically novel mode of action. Methods: An open-label, single-arm, Phase II study of eribulin was conducted in patients with advanced NSCLC (ECOG of 0 or 1) who were treated with platinum-based doublet chemotherapy and stratified by prior taxane exposure. A total of 103 patients (83 with prior taxanes and 20 taxane naïve) were treated with eribulin (1.4 mg/m2), administered as a bolus infusion over 2 –5 minutes on Days 1, 8, and 15 of a 28-day cycle (N=77). Due to delays or skipped doses secondary to myelosuppression at Day 15 with recovery by Day 21, the protocol was amended to a schedule of Days 1 and 8 of a 21-day cycle (N=26). The primary efficacy endpoint was objective response rate. Independent radiologic review was used to confirm responses. Results: Of 106 enrolled patients, 103 received eribulin. Median age was 65 years and median number of prior therapies was 2, including taxanes (81%), gemcitabine (40%), pemetrexed (23%), and EGFR inhibitors (34%). Median number of cycles administered was 3 (range 1–15). Drug related toxicities included neutropenia grade 3 (23%) and 4 (26%), febrile neutropenia (4%), grade 3 fatigue (11%), grade 3 nausea (2%), and peripheral neuropathy grade 1/2 (37%) and 3 (2%). Based on RECIST criteria, the overall response rate (all partial responses) was 9.7% (95% CI: 4.0–15.4 %), with 10.8% PR in taxane pre-treated, and 5% PR in taxane naïve patients. Overall disease control rate (PR + SD) was 55.3%. 12-week progression free survival (PFS) rate was 53.0% (95% CI: 42.6–63.3%) and median PFS was 102 days (range 1–408+). Median duration of response was 176 days (range 50–291+), and median overall survival was 287 days (range 16–423+). The one year survival rate was 46.4% (95% CI: 34.9–58.0%). Conclusions: In this group of NSCLC patients who were treated with a median of two prior therapies, consisting in the majority of cases of two cytotoxic regimens, eribulin demonstrated an overall PR rate of 9.7% (10.8% in the taxane pre-treated) and 9.6 months median survival. No significant financial relationships to disclose.

Phase II trial of pemetrexed (P) and gemcitabine (G) as first-line chemotherapy for elderly and/or poor performance status patients with stage IIIB/IV non-small cell lung cancer (NSCLC)

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 17031-17031
Author(s):  
J. Blakely ◽  
F. Schnell ◽  
P. Kaywin ◽  
M. Keaton ◽  
B. Fortner ◽  
...  
Keyword(s):  
Performance Status ◽  
Objective Response ◽  
Locally Advanced ◽  
Poor Performance ◽  
Median Number ◽  
Maximum Tolerated Dose ◽  
Stage Iiib ◽  
Poor Performance Status ◽  
Female Ratio ◽  
Grade 3

17031 Background: Pemetrexed and gemcitabine have shown to be active agents in the treatment of locally advanced or metastatic NSCLC with favorable toxicity profiles. A recent phase I study examined a biweekly schedule of P and G in combination in order to establish a maximum tolerated dose in solid tumors. (Dudeck, A. ASCO 2004 Abstract 2141.) This established the dose for this study. Methods: After informed consent all patients received biweekly cycles of P 500 mg/m2 IV 10 minutes before G 1500 mg/m2 IV. A maximum of 12 cycles was planned for stable or responding patients. All patients received vitamin B12 1000 μg and folic acid 1000 mg 7 days prior to the initiation of treatment and continued through treatment. Entry criteria include measurable stage IIIB/IV NSCLC by RECIST criteria, age ≥65 years and ECOG 0–2 or <65 years and ECOG of 2. A total of 40 patients are scheduled to be enrolled. Primary endpoint is objective response rate. Results: To date, 19 of 29 enrolled patients have data available for analysis. The median age is 71 (range 61–85). 2 had stage IIIB and 17 stage IV, median number of sites of disease is 2. Male/Female ratio was 10/9. Performance status was as follows ECOG 0 = 3 patients, 1 = 12 patients, 2 = 4 patients. 3 patients had grade 3 or 4 neutropenia with only 1 patient having neutropenic fever. There were no grade 3 or 4 anemias or thrombocytopenias. One patient had grade 3/4 nausea; there were no other severe non-hematologic toxicities. 14 patients were evaluable for response with 3 achieving PR (21%), 10 with SD (71%) (median number of cycles 7) and 1 with PD (7%). Conclusion: Pemetrexed and gemcitabine in combination biweekly has substantial activity with a favorable toxicity profile for patients with advanced NSCLC who are elderly or have poor performance status. The study is expected to be completed and fully evaluable by ASCO. No significant financial relationships to disclose.

Randomized, single-centered, phase II clinical trial of nimotuzumab plus cisplatin and S-1 as first-line therapy in patients with advanced gastric cancer.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e14668-e14668 ◽  
Author(s):  
Jin-Wan Wang ◽  
Yihebali Chi ◽  
Zhao-xu Zheng ◽  
Tao Qu ◽  
Ai-Ping Zhou ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Adverse Events ◽  
Performance Status ◽  
Objective Response ◽  
Survival Rates ◽  
Skin Toxicity ◽  
Metastatic Gastric Cancer ◽  
Open Label ◽  
First Line Therapy ◽  
Grade 3

e14668 Background: Nimotuzumab, a humanized IgG1 anti-EGFR monoclonal antibody, has demonstrated efficacy associated with an absence of severe skin toxicity in many phase I/II cancer trials. Methods: This is a single-center, parallel assignment and open-label study randomized to receive a infusion Cisplatin (30mg/m2/d, on day 1 and 2) and oral S-1 (80mg/m2/d, twice daily on day 1-14) every 3 weeks, either alone or together with Nimotuzumab (200 mg as a infusion on day 1, 8 and 15) (CS or NCS) as 1st line in patients with advanced or metastatic gastric cancer. The observation points were ORR, TTP, PFS, 1-year survival rates and safety. Results: 62 patients, 43 men and 19 women, median age 57 years (22-76 years), on good performance status (ECOG PS 0-2, one prior regimen) were treated with NCS (n = 31) or CS (n = 31). Up to 2012-01-16, 57 patients (NCS 30 cases compared with CS 27 cases) have undergone efficacy assessment. The objective response rate (ORR: PR 15) was 50% (15/30) in NCS group compared with (ORR: pCR 2+ PR 15) 63.0% (17/27) in CS group. Disease control rate was 96.7% and 96.3%, respectively. Until the same day, 36 patients have achieved progression in both groups (NCS 15: CS 11), median TTP was 5 months in NCS group compared with 3 months in CS group, and average TTP was 4.9 months and 4 months, respectively. The incidence of adverse events was similar between both groups. Adverse events included grade 3/4 hypo-hemoglobin 13.33%/7.41%, grade 3/4 thrombocytopenia 3.33%/0 and grade 3/4 neutropenia 3.33%/0. One patient experienced grade 3/4 digestive side effects 3.33%/0. Conclusions: The results have demonstrated benefit in TTP improvement. Further investigation is ongoing.

Phase II study of docetaxel and cisplatin in advanced non-small-cell lung cancer.

1998 ◽  
Vol 16 (5) ◽  
pp. 1948-1953 ◽  
Author(s):  
J Zalcberg ◽  
M Millward ◽  
J Bishop ◽  
M McKeage ◽  
A Zimet ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Phase Ii ◽  
Advanced Nsclc ◽  
Response Rate ◽  
Phase Ii Study ◽  
Performance Status ◽  
Objective Response ◽  
Small Cell ◽  
Small Cell Lung ◽  
Grade 3

PURPOSE Docetaxel (Taxotere, Rhone-Poulenc Rorer, Antony, France) and cisplatin are two of the most active single agents used in the treatment of non-small-cell lung cancer (NSCLC). A recently reported phase I study of the combination of docetaxel and cisplatin recommended a dose of 75 mg/m2 of both drugs every 3 weeks for subsequent phase II study. PATIENTS AND METHODS Eligible patients were aged 18 to 75 years with a World Health Organization (WHO) performance status < or = 2 and life expectancy > or = 12 weeks, with metastatic and/or locally advanced NSCLC proven histologically or cytologically. Patients were not permitted to have received prior chemotherapy, extensive radiotherapy, or any radiotherapy to the target lesion and must have had measurable disease. Concurrent treatment with colony-stimulating factors (CSFs) or prophylactic antibiotics was not permitted. Docetaxel (75 mg/m2) in 250 mL 5% dextrose was given intravenously (i.v.) over 1 hour immediately before cisplatin (75 mg/m2) in 500 mL normal saline given i.v. over 1 hour in 3-week cycles. Premedication included ondansetron, dexamethasone, promethazine, and standard hyperhydration with magnesium supplementation. RESULTS A total of 47 patients, two thirds of whom had metastatic disease, were entered onto this phase II study. The majority of patients were male (72%) and of good (WHO 0 to 1) performance status (85%). All 47 patients were assessable for toxicity and 36 were for response. Three patients were ineligible and eight (17%) discontinued treatment because of significant toxicity. In assessable patients, the overall objective response rate was 38.9% (95% confidence limits [CL], 23.1% to 56.5%), 36.1% had stable disease, and 25% progressive disease. On an intention-to-treat analysis, the objective response rate was 29.8%. Median survival was 9.6 months and estimated 1-year survival was 33%. Significant (grade 3/4) toxicities included nausea (26%), hypotension (15%), diarrhea (13%), and dyspnea mainly related to chest infection (13%). One patient experienced National Cancer Institute (NCI) grade 3 neurosensory toxicity after eight cycles. Grade 3/4 neutropenia was common and occurred in 87% of patients, but thrombocytopenia > or = grade 3 was rare (one patient). Significant (grade 3/4) abnormalities of magnesium levels were common (24%). Febrile neutropenia occurred in 13% of patients and neutropenic infection in 11%, contributing to two treatment-related deaths. No neutropenic enterocolitis or severe fluid retention was reported. CONCLUSION Compared with other active regimens used in this setting, the combination of docetaxel and cisplatin in advanced NSCLC is an active regimen with a similar toxicity profile to other combination regimens.

scholarly journals Concurrent chemoradiotherapy with S-1 compared with concurrent chemoradiotherapy with docetaxel and cisplatin for locally advanced esophageal squamous cell carcinoma

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Xi-Lei Zhou ◽  
Chang-Hua Yu ◽  
Wan-Wei Wang ◽  
Fu-Zhi Ji ◽  
Yao-Zu Xiong ◽  
...  
Keyword(s):  
Squamous Cell Carcinoma ◽  
Adverse Events ◽  
Esophageal Squamous Cell Carcinoma ◽  
Elderly Patients ◽  
Cell Carcinoma ◽  
Squamous Cell ◽  
Concurrent Chemoradiotherapy ◽  
Response Rate ◽  
Locally Advanced ◽  
Grade 3

Abstract Background This retrospective study was to assess and compare the toxicity and efficacy of concurrent chemoradiotherapy (CCRT) with S-1 or docetaxel and cisplatin in patients with locally advanced esophageal squamous cell carcinoma (ESCC). Methods Patients with locally advanced ESCC who received CCRT with S-1 (70 mg/m2 twice daily on days 1–14, every 3 weeks for 2 cycles, S-1 group) or docetaxel (25 mg/m2) and cisplatin (25 mg/m2) on day 1 weekly (DP group) between 2014 and 2016 were retrospectively analyzed. Radiotherapy was delivered in 1.8–2.0 Gy per fraction to a total dose of 50–60 Gy. Treatment-related toxicities (Common Terminology Criteria for Adverse Events version 4.0), response rate, and survival outcomes were compared between groups. Results A total of 175 patients were included in this study (72 in the S-1 group and 103 in the DP group). Baseline characteristics were well balanced between the two groups. The incidence of grade 3–4 adverse events were significantly lower in the S-1 group than that of the DP group (22.2% vs. 45.6%, p = 0.002). In the DP group, elderly patients (> 60 years) had a significantly higher rate of grade 3–4 adverse events than younger patients (58.1% vs. 31.3%, p = 0.01). The objective overall response rate (complete response + partial response) was 68.1% in the S-1 group, and 73.8% the DP group (p = 0.497). The 3-year overall survival was 34.7% in the S-1 group, and 38.8% in the DP group (p = 0.422). The 3-year progression free survival in the DP group was higher than that in the S-1 group but without significant difference (33.0% vs. 25.0%, p = 0.275). Conclusion CCRT with S-1 is not inferior to CCRT with docetaxel and cisplatin and is better tolerated in in elderly patients with locally advanced ESCC.

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