Outcomes of advanced stage non-small cell lung cancer (NSCLC) patients reexposed to platinum-based chemotherapy upon progression

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 17136-17136
Author(s):  
P. H. Souza ◽  
A. N. Rodrigues ◽  
R. Dienstmann ◽  
I. A. Small ◽  
W. Roriz ◽  
...  
Keyword(s):  
Disease Progression ◽  
Progression Free Survival ◽  
Median Number ◽  
Advanced Stage ◽  
Line Treatment ◽  
Consensus Definition ◽  
Platinum Based Chemotherapy ◽  
Number Of Cycles ◽  
Ecog Ps ◽  
Nsclc Patients

17136 Background: Platinum-based chemotherapy (PtCT) is the standard 1st-line treatment for advanced stage NSCLC patients. Nearly all patients (pts) that respond to 1st-line CT will relapse and some of them will be candidates for 2nd-line CT. There is no consensus definition of sensitive or resistant pts to PtCT and there are conflicting results about the relationship between response to prior PtCT and response to a 2nd-line reexposure. The aim of this study was to evaluate the outcomes of a subset of pts considered sensitive to platinum, who were reexposed to a PtCT regimen as 2nd-line CT. Methods: Based on a criterion of disease progression > 6 months of completing 1st-line as a hallmark platinum-sensitivity, pts were retrospectively selected. We reviewed the outcomes of 11 advanced NSCLC pts (stages IIIB or IV) treated between Jan 2000 and Jun 2005 at 1st-line with a PtCT (cisplatin or carboplatin combined to etoposide) and who upon progression were reexposed to a regimen of Carboplatin plus etoposide. Pts were evaluated for overall (OS) and progression-free survival (PFS) after 1st- and 2nd-line CT by Kaplan-Meyer method. Results: There were 6 women (54.5%) and 5 men (45.5%). Median age was 62 (range 49–78) and adenocarcinoma was the most prevalent histology (54.5%). At 1st-line CT, 6 patients (54.5%) were stage IIIB and ECOG PS 0/1 were 36.4 and 63.6%, respectively. The median number of cycles per patient was 6 (range 2–8) at 1st-line and 4 (range 2–4) at 2nd-line treatment. With a median follow-up of 29 months, there were 4 deaths (36.5%) with a median OS of 49 months (CI 95%; 29.38–68.62). The median PFS after first-line was 17 months (IC 95%; 13.87–20.13). To date, 7 pts have progressed after 2nd-line CT with a median PFS of 8 months (IC 95%; 5.92–10.09). Conclusions: This subset of pts with longer progression-free interval (> 6 months) after 1st-line PtCT seems to remain sensitive to platinum compounds upon disease progression. Despite the high proportion of stage III in our sample, based on the long DFS and OS observed, it seems that this population has a more favorable biology than the general population with NSCLC. Further studies, in particular pharmacogenetic analyses, are needed in order to better characterize and treat this population. No significant financial relationships to disclose.

Phase II study of bevacizumab in combination with cisplatin and docetaxel as first-line treatment of patients (p) with metastatic non-squamous non-small cell lung cancer (NSCLC)

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e19023-e19023
Author(s):  
N. Ferrer ◽  
M. Cobo ◽  
A. Paredes ◽  
M. Méndez ◽  
J. Muñoz-Langa ◽  
...  
Keyword(s):  
Phase Ii ◽  
Stage Iv ◽  
Progression Free Survival ◽  
Median Number ◽  
Line Treatment ◽  
Eligibility Criteria ◽  
Platinum Based Chemotherapy ◽  
History Of ◽  
Grade 3 ◽  
Number Of Cycles

e19023 Background: Bevacizumab (B), in addition to platinum-based chemotherapy, is indicated for 1st-line treatment of p with advanced NSCLC other than predominantly squamous cell histology. B has been shown to improve progression free survival (PFS) and overall survival (OS) when combined with cisplatin/gemcitabine and carboplatin/paclitaxel, respectively. However, there are limited data on the safety and efficacy of B in combination with other widely used chemotherapy doublets for NSCLC. This is a single-arm, open- labeled, single-stage phase II trial of cisplatin (C), docetaxel (D) and B for NSCLC. Methods: Eligibility criteria: chemo- naïve, stage IIIB wet or IV, non-squamous NSCLC, PS 0–1, no brain metastases and no history of gross hemoptysis. P received D (75 mg/m2), C (75 mg/m2), and B (15 mg/kg iv) on day 1 every 3 weeks for up to 6 cycles, followed by B 15 mg/kg alone every 3 weeks until disease progression or toxicity. Primary endpoint: PFS. Results: 50 p were enrolled (enrollment completed): 24% female, median age 60 (36–74), PS 1: 64%, adenocarcinoma: 72%; stage IV: 92%. Two p did not start treatment. Median follow-up is 5.3 months (range 0–13.6). Median number of cycles of B was 7 (range 0–18). 56% completed 6 cycles of treatment; 24% received ≥ 12 cycles of B. Most frequent grade ≥ 3 toxicities: diarrhea (14.6%), fatigue (14.6%), dyspnea (9.8%), anorexia (4.9%), alopecia (4.9%), esophagitis (4.9%), constipation (4.9%), mucositis (12.2%), proteinuria (4.9%); hematological toxicities: neutropenia (22%), febrile neutropenia (9.8%), leucopenia (14.6%), lymphopenia (4.9%). Of interest, 41.5% developed grade <3 epistaxis and 17% hypertension (1 p grade 3). One p died due to hemoptysis. 46 p were evaluable for response: 29 PRs (ORR: 63%). 18 of 48 p have experienced progression or death with a median SLP of 7.8 months (95% CI: 6.6-NR). Median OS is 13.5 months (95% CI: 12.7–13.6; 81.2% p censored); 1-year survival is 83.9% (95% CI: 67.4%-92.5%). Conclusions: Treatment with C, D and B, followed by maintenance B in 1st line of advanced non-squamous NSCLC shows an acceptable toxicity profile and promising efficacy. Final results will be presented. [Table: see text]

Efficacy of oral chemotherapy with capecitabine and temozolomide (CapTem) in metastatic neuroendocrine tumors (NETs): A single-institution experience.

2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 487-487 ◽  
Author(s):  
Valeria Smiroldo ◽  
Carlo Carnaghi ◽  
Lorenza Rimassa ◽  
Nicola Personeni ◽  
Tiziana Pressiani ◽  
...  
Keyword(s):  
Primary Tumor ◽  
Kinase Inhibitors ◽  
Symptom Control ◽  
Progression Free Survival ◽  
Median Number ◽  
Oral Chemotherapy ◽  
Line Treatment ◽  
Entire Cohort ◽  
Tumour Shrinkage ◽  
Number Of Cycles

487 Background: CapTem chemotherapy regimen represents one of the standard of treatment for NETs, an interesting option of care due to its feasibility and efficacy although not enough prospective data support this evidence. Methods: This retrospective analysis included all patients (pts) with metastatic NETs treated with CapTem regimen at our institution from April 2013 to April 2017. This oral chemotherapy included capecitabine 600 mg/m2/BID (capped at 1,000 mg BID total dose) on days 1–14 and temozolomide 75 mg/m2/BID on days 10–14 every 28 days according to the schedule published by Fine RL et al. (Cancer Chemother Pharmacol, 2013). Overall survival (OS), progression free survival (PFS), overall response rate (ORR) and toxicities were retrospectively evaluated. Results: Twenty-seven pts (15 males) were included. Median age was 61 yrs (range 46-85). Primary tumor included pancreas in 8 pts (29.6%), midgut 8 pts (29.6%), lung 8 pts (29.6%), other NETs 3 pts (11.1%). Most of pts had well-differentiated tumors (88.8%) and Ki67 was less than <20% in 59% of pts. Median number of cycles was 6 (range 2-25). Ten pts (37.0%) received CapTem as 1st line treatment, 7 pts (25.9%) as 2nd line and 10 (37.0%) pts as > 3rd line. ORR was 33.3%; 31.2% for Ki67 < 20% group and 40.0% in Ki67 >20%. DCR (partial response + stable disease) for the entire cohort was 59.2%. Median PFS was 4 mos, without any differences between pancreatic, midgut and lung groups, but mPFS was 8.0 mos for pts who received CapTem as 1st line treatment. At present mOS was not reached. In term of toxicity CapTem regimen was very well tolerated and only 1 pt reported a G3 reversible toxicity (neutropenia). No G3/4 toxicity were observed. Conclusions: Our experience confirms that CapTem regimen is effective and well tolerated. Efficacy does not seem to be related to the primary tumor or Ki67. DCR and ORR are superior to the response produced by tyrosine kinase inhibitors, suggesting a strategy when tumour shrinkage and symptom control are needed.

ECOG 1503: A phase II trial of triapine (NSC#663249) with gemcitabine (T/G) as 2nd line treatment of non-small cell lung cancer (NSCLC)

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 17151-17151 ◽  
Author(s):  
A. M. Traynor ◽  
D. E. Levy ◽  
G. K. Bayer ◽  
J. M. Tate ◽  
S. P. Thomas ◽  
...  
Keyword(s):  
Advanced Nsclc ◽  
Phase Ii Trial ◽  
Progression Free Survival ◽  
Median Number ◽  
Primary Objective ◽  
Line Treatment ◽  
Wild Type ◽  
Free Survival ◽  
Number Of Cycles ◽  
Dna Incorporation

17151 Background: Triapine (3-aminopyridine-2-carboxaldehyde thiosemicarbazone) is a novel chelator of the ribonucleotide reductase (RR) subunit M2. Triapine was shown to enhance cellular uptake and DNA incorporation of gemcitabine in tumor cell lines. Preclinical evidence suggested that cells with the wild-type (wT) MDR1 gene may have lower intratumoral concentrations of Triapine. Objectives: Primary objective was response rate (RR). Secondary objectives included rate of stable disease (SD), progression free survival (PFS), overall survival (OS), and safety of T/G in the 2nd line treatment of advanced NSCLC. Correlative objectives were to examine the effects of MDR1 polymorphisms, RRM1, RRM2, and p53R2 protein and gene expression, and germline and tumor mutations of p53 on clinical outcomes. Methods: Pts with relapsed NSCLC who failed one prior cytotoxic regimen were eligible; prior gemcitabine was excluded. Treatment: Triapine 105 mg/m2 IV on days 1, 8, and 15 and gemcitabine 1000 mg/m2 on days 1, 8, and 15, of a 28 day cycle. Results: 18 pts enrolled from 11/04–1/05. Stage: IIIB (1 pt); IV (17 pts). PS: 0 (4 pts); 1 (14 pts). Median number of cycles administered: 2. No objective antitumor responses were seen. 5 pts experienced SD (range 7–135 days). Median OS: 5.4 mo (95%CI 3.98, not yet reached); median PFS: 3.2 mo (95%CI 1.7, 6.4); estimated 1 yr OS: 39% (SE 13%). Worst Gr 3/4 toxicities: leucopenia (Gr 3–8 pts; Gr 4–1 pt), neutropenia (Gr 3–8 pts; Gr 4–2 pts), hypoxia (Gr 3–4 pts), vomiting (Gr 3–2 pts). Genotyping for MDR1 polymorphisms C1236T, G2677T, and C3435T was performed on all pts. None of the 5 pts with SD were wTs. Pts with wT MDR1 had increased GI and pulmonary toxicity. Additional correlative data will be available for the meeting. Conclusions: T/G did not demonstrate clinically relevant activity in relapsed NSCLC. Genotyping for MDR1 polymorphisms may predict both efficacy and toxicity. [Table: see text]

Amrubicin monotherapy for patients with platinum-refractory gastroenteropancreatic neuroendocrine carcinoma.

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 328-328
Author(s):  
Takayuki Ando ◽  
Ayumu Hosokawa ◽  
Hiroki Yoshita ◽  
Akira Ueda ◽  
Shinya Kajiura ◽  
...  
Keyword(s):  
Partial Response ◽  
Neuroendocrine Carcinoma ◽  
Progression Free Survival ◽  
Median Number ◽  
Line Treatment ◽  
First Line ◽  
Ki 67 ◽  
Platinum Based Chemotherapy ◽  
Platinum Refractory ◽  
First Line Treatment

328 Background: Patients with gastroenteropancreatic neuroendocrine carcinoma (NEC) have a poor prognosis. Platinum-based combination chemotherapy is commonly used as first-line treatment; however, because studies on salvage chemotherapy are limited, its role remains unknown. This study aimed to analyze the efficacy and safety of amrubicin monotherapy in patients with platinum-refractory gastroenteropancreatic NEC. Methods: Among 22 patients with advanced gastroenteropancreatic NEC, 10 received amrubicin monotherapy between September 2006 and May 2014 after failure of platinum-based chemotherapy. The efficacy and toxicity of the treatment were analyzed retrospectively. Results: Eight males and two females ((median age, 67 years (range, 52–78)) received platinum-based chemotherapy, including cisplatin plus irinotecan (n = 7, 70%), cisplatin plus etoposide (n = 2, 20%), and carboplatin plus etoposide (n = 1, 10%) before amrubicin therapy. A total of 30 cycles of amrubicin was administered in 10 patients, with a median number of cycles per patients was 2.5 (range, 1-7). Median progression-free survival (PFS) and overall survival after amrubicin therapy were 2.6 and 5.0 months, respectively. Two patients had partial response (20% response rate), and their PFS were 6.2 months and 6.3 months, respectively. Two patients with partial response had characteristics of NEC with a high Ki-67 index (99% and 89%, respectively) and had received cisplatin and irinotecan as first-line treatment. Grade 3–4 neutropenia and anemia were observed in four (40%) and five (50%) patients, and they were manageable in all cases by careful monitoring of myelosuppression and appropriate dose reduction of amrubicin. Conclusions: Amrubicin monotherapy appears to be potentially active and well-tolerated for platinum-refractory gastroenteropancreatic NEC.

A phase II trial of biweekly pemetrexed (P) and gemcitabine (G) in the first-line treatment (tx) of patients (pts) with advanced non-small cell lung cancer (NSCLC)

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 17054-17054 ◽  
Author(s):  
N. W. Peacock ◽  
D. R. Spigel ◽  
J. D. Hainsworth ◽  
D. A. Yardley ◽  
H. A. Burris ◽  
...  
Keyword(s):  
Phase Ii ◽  
Progression Free Survival ◽  
Large Cell ◽  
Median Number ◽  
Hematologic Toxicity ◽  
First Line ◽  
Adequate Organ Function ◽  
Intent To Treat ◽  
Number Of Cycles ◽  
Ecog Ps

17054 Background: P and G are active and well-tolerated non-platinum agents used in the tx of NSCLC. Previous trials have combined P and G in the first-line NSCLC setting using a 21D schedule. This trial examined the safety and activity of biweekly P/G. Methods: Theprimary endpoints of this single center community-based phase II study were toassess the safety and response rate (RR) of P/G in pts with previously untreated stage III (unresectable) or IV NSCLC. Tx included: P 500mg/m2 IV D1 and G 1500mg/m2 IV D1 Q 14D for 8–12 cycles. Pts also received folate and B12 prophylaxis. Pts were restagedafter 4 cycles. Eligibility included:measurable disease, ECOG PS 0–2, adequate organ function, informed consent, and no active brain metastases. Analysis was by intent to treat. Results: Thirty-five pts were enrolled between 5/05 and 8/05. The median follow-upis 6 months (3.5–7.5 months). Baseline characteristics include: medianage 65 years (41–85); male/female, 71%/29%; ECOG PS 0,1,2:17%/71%/12%; and histology, adenocarcinoma (34%), large cell (29%), squamous (11%), mixed or not specified (26%). The median number of cycles delivered was 8 (1–12). Grade (G)3/4 non-hematologic toxicity included:chest pain (6%), constipation (6%), fatigue (17%), hypercalcemia (6%), dyspnea (9%), and tachyarrhythmia (9%). G3/4 hematologic toxicity included: neutropenia(51%), anemia (8%), and thrombocytopenia (3%). G3/4 febrile neutropenia occurred in 14%. There were notx-related deaths. Response data are availablefor 35 pts. Complete/partial responses for all pts were observed in 0 pts/7pts, respectively, for an overall RR of 20% (95% CI 10%-36%, 1 pt unconfirmed by RECIST criteria). Fifty-four percentof pts had stable disease, and 14% had disease progression(4 pts were unevaluable.) Six-month progression-free survival (PFS) andoverall survival (OS) were 51% and 67%, respectively. Median PFS and OS have not been reached. Conclusions: Biweekly P/G is a safe and well-tolerated regimen with RRsimilar to other standard first-line regimens for the tx of pts with advanced NSCLC, and further study is warranted. Median and 1-year PFSand OS endpoints have not been reached in this trial. [Table: see text]

Results of a randomized phase II trial of amrubicin (AMR) versus topotecan (Topo) in patients with extensive-disease small cell lung cancer (ED-SCLC) sensitive to first-line platinum-based chemotherapy

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 8028-8028
Author(s):  
R. Jotte ◽  
P. Conkling ◽  
C. Reynolds ◽  
L. Klein ◽  
J. F. Fitzgibbons ◽  
...  
Keyword(s):  
Phase Ii ◽  
Performance Status ◽  
Single Agent ◽  
Progression Free Survival ◽  
Line Treatment ◽  
Open Label ◽  
Ecog Performance Status ◽  
Prior Therapy ◽  
Platinum Based Chemotherapy ◽  
Ecog Ps

8028 Background: SCLC presents as ED-SCLC in 60%-70% of patients (pts). AMR, a synthetic anthracycline, is approved for these pts in Japan. We compare the efficacy and safety of single-agent AMR vs topotecan in non-Japanese pts with 2nd-line ED-SCLC sensitive to 1st-line platinum-based chemotherapy. Methods: This phase II, open-label, multicenter study enrolled pts with ED-SCLC sensitive to 1st-line platinum-based chemotherapy (recurrence or progression ≥90 days from 1st-line treatment). Pts aged ≥18 years with ECOG performance status (PS) ≤2 and only 1 prior therapy were eligible. Pts were randomized (2:1) to receive IV AMR 40 mg/m2/d (d, 1–3) or IV topotecan 1.5 mg/m2/d (d 1–5) and treated every 21 days until progression, unacceptable toxicity, or withdrawal. The primary endpoint, overall response rate (ORR, complete + partial response), used RECIST criteria. Secondary endpoints were progression-free survival (PFS), overall survival (OS), and safety. Results: In all, 76 pts were randomized to AMR (n=50) or topotecan (n=26) with AMR given for a median of 6 cycles (range 1–16) and topotecan 3 cycles (1–16). AMR significantly improved ORR rates vs topotecan (p<0.012; Table ). Median PFS/OS was 4.3 months (95% CI 2.0, 6.1)/9.3 months (95% CI 5.7, 12.0) with AMR vs 3.5 months (95% CI 2.1, 6.3)/8.9 months (95% CI 4.8, 13.8) with topotecan. There was a higher proportion of ECOG PS 2 pts in the AMR group (n=6) vs the topotecan group (n=2). A trend towards improved OS was observed in the ECOG 0–1 subgroup of 68 pts: median OS was 10.5 months with AMR vs 9.7 months with topotecan. The most common grade ≥3 adverse events with AMR vs topotecan were neutropenia (53% vs 74%), thrombocytopenia (31% vs 52%) and leukopenia (27% vs 30%). Three AMR pts (6%) and 1 topotecan pt (4%) died of neutropenic infection. Conclusions: AMR significantly improves ORR and has acceptable tolerability as 2nd-line treatment in pts with sensitive ED-SCLC. [Table: see text] [Table: see text]

A phase Ib study to evaluate the safety and efficacy of AMG 655 in combination with gemcitabine (G) in patients (pts) with metastatic pancreatic cancer (PC)

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 4501-4501 ◽  
Author(s):  
H. L. Kindler ◽  
L. Garbo ◽  
J. Stephenson ◽  
J. Wiezorek ◽  
T. Sabin ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Single Agent ◽  
Objective Response ◽  
Death Receptor ◽  
Progression Free Survival ◽  
Median Number ◽  
Metastatic Pancreatic Cancer ◽  
Death Receptor 5 ◽  
Number Of Cycles ◽  
Ecog Ps

4501 Background: AMG 655 is an investigational, fully human agonist monoclonal antibody (IgG1) that binds human death receptor 5 (DR5), activates caspases, and induces apoptosis in sensitive tumor cells. In preclinical PC models, cooperative activity is observed when G is added to AMG 655. We performed a multi-center phase I trial to evaluate AMG 655 + G in metastatic PC pts. The primary endpoint was dose-limiting toxicity (DLT). Secondary endpoints included toxicity, pharmacokinetics, antibody formation, objective response rate, progression-free survival (PFS), 6-month and overall survival. Methods: Eligible pts had previously untreated metastatic PC and ECOG PS 0 or 1. Pts enrolled into sequential cohorts and received AMG 655 3 or 10 mg/kg IV days (D) 1 and 15 and G 1000 mg/m2 IV D 1, 8, and 15 every 28 D. CT scans were obtained Q8 weeks. Results: 13 pts (3 mg/kg cohort = 6; 10 mg/kg cohort = 7) enrolled from 7/07–11/07. Pt characteristics: females 61%; ECOG PS 1 69%; median age 65 (range 35–81); liver metastases 77%. Median number of cycles: 6 (range 2–12). There were no DLT. Nine (69%) pts had grade 3–4 toxicity, the most common were: thrombocytopenia (4 pts), neutropenia (2 pts), and abdominal pain (2 pts). No anti-AMG 655 antibodies were detected. After one 3 or 10 mg/kg dose of AMG 655 after G, the Cmax and AUC of AMG 655 were similar to those in the first- in-human single-agent study (LoRusso JCO 2007; 25: abstract 3534). Preliminary data indicate no effect of AMG 655 on PK of G. Partial response 31% (4 pts, 2 unconfirmed); stable disease 38%. Median PFS: 5.3 months (95% CI, 3.5, 6.2); 6-month survival rate: 76.2% (95% CI: 42.7%-91.7%). Conclusions: AMG 655 + G is well-tolerated and may have activity in metastatic pancreatic cancer. A randomized phase II trial of G ± AMG 655 at 10-mg/kg is currently enrolling. [Table: see text]

Phase II trial of ifosfamide in combination with sorafenib in patients with advanced soft tissue sarcoma: A Spanish Group for Research on Sarcomas (GEIS) study.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 10523-10523
Author(s):  
Xavier Garcia del Muro ◽  
Joan Maurel ◽  
Javier Martinez Trufero ◽  
Javier Lavernia ◽  
Antonio Lopez-Pousa ◽  
...  
Keyword(s):  
Soft Tissue ◽  
Soft Tissue Sarcoma ◽  
Phase Ii ◽  
Progression Free Survival ◽  
Hepatic Function ◽  
Median Number ◽  
Hand Foot Syndrome ◽  
Number Of Cycles ◽  
Histologic Types ◽  
Ecog Ps

10523 Background: Recent studies suggest that VEGFR inhibition could play a role in the treatment of soft tissue sarcoma (STS). Prior studies by our group showed that the combination of ifosfamide with sorafenib resulted in preclinical additive activity and that was feasible and safe in the phase I trial. Methods: Patients (pts) with advanced STS, previously treated with doxorubicin, no prior ifosfamide, ECOG PS 0-2, and adequate hematological, renal and hepatic function, were enrolled in this multicenter phase II study, receiving sorafenib 400 mg bid po continuously and ifosfamide 2 g/m2 iv for 3 days together with mesna 400 mg/m2 every 3 weeks. The primary endpoint was progression-free rate (PFR) at 3 months. A one-sample binomial design was used (PFR P0=40%, P1=60%, α=0.10, β=0.20), requiring at least 19 of 35 pts free of progression at 3 months to be considered positive. Results: From September 09 to March 12, 35 pts were enrolled at 11 centers. Median age was 55 (18-73). PS: 0-13, 1-18; 2-4 pts. Histologic types were: LMS 12, Lipo 6, SS 5, MPNST 2, other 10 pts. . The median number of cycles administered per patient was 4. PFR at 3 months was 67%, with 23 pts being free of progression at 3 months. Median progression-free survival was 4.8 months (95% CI, 1.9-6.3) and median overall survival was 16.2 months. PR was achieved in 17% pts. Most common grade 3-4 toxicities were asthenia (25%), hand-foot syndrome (11%) and neutropenia (20%) resulting in 3 episodes of neutropenic fever. Other common toxicities (G1-4) included emesis (34%), rash (22%), diarrhea (34%), hypertension (11%) and mucositis (9%). Conclusions: The combination of ifosfamide and sorafenib is active and has acceptable toxicity in pts with doxorubicin pretreated STS. The PFR at 3 months might exceed the expected with ifosfamide alone warranting further investigation. Clinical trial information: EudraCT: 2007-002176-34.

Comparison of survival of African-American (AA) patients (pts) in docetaxel (D)-based combination therapies in metastatic castrate-resistant prostate cancer (mCRPC).

2016 ◽  
Vol 34 (2_suppl) ◽  
pp. 272-272
Author(s):  
Fatima Karzai ◽  
Ravi Amrit Madan ◽  
Yang-Min Ning ◽  
Marc Robert Theoret ◽  
Philip M. Arlen ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Specific Antigen ◽  
Progression Free Survival ◽  
Median Number ◽  
Incidence And Mortality ◽  
Castrate Resistant Prostate Cancer ◽  
Castrate Resistant ◽  
Number Of Cycles ◽  
Ecog Ps

272 Background: AA pts experience greater prostate cancer (PC) incidence and mortality compared to Caucasian (C) pts but are underrepresented in clinical trials (CTs). Greater representation of AAs is required to explore differences in clinical benefit in advanced disease where recent data has reaffirmed the role of D. Methods: In a retrospective analysis, baseline characteristics, Gleason score (GS), ECOG PS, number of cycles (cys), maximum prostate-specific antigen (PSA) declines, radiographic responses, overall survival (OS) and progression-free survival (PFS) were captured in 2 recent D based CTs. Results: Of 136 pts, 28 (21%) self-identified as Black or AA. Median age of AA pts is 66 (50-78 yrs). Median GS is 8 (5-10). Median ECOG PS is 1 (0-2). 15 pts have bone and soft tissue disease; 13 pts have bone only disease. Median number of cys is 28.5 (1-63). Of 27 evaluable pts, 26 had PSA declines (-26 to -99%). Radiographic responses include 11 (39%) partial responses and 16 (57%) pts with stable disease. Median OS for AAs is 29.0 months (mos) (95% CI: 20.9-34.7 mos); median PFS is 21.5 mos (95% CI: 13.7-28.9 mos). Median OS for all non-AA pts is 24.8 mos (95% CI: 21.8-29.5 mos); median PFS is 16.1 mos (95% CI: 14.1-20.1 mos). The VEGF-634G > C SNP, associated with a more aggressive phenotype of PC, was evaluated in 54 pts. No evidence was found that genotype frequency varies between C and AA pts. Conclusions: In this analysis, AA pts did not have inferior OS (29 mos) or PFS (21.5 mos) outcomes compared to non-AA pts (24.8, 16.1 mos). Further analysis from larger studies is required to determine differential benefits of D for AA pts compared to non-AA pts. Clinical trial information: NCT00089609, NCT00942578.

The advantage of pemetrexed combined with platium chemotherapy treatement for advanced nonsquamous non-small-cell lung cancer (NSCLC) patients without drive oncogene.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e20527-e20527
Author(s):  
Haiyan Xu ◽  
Yan Wang
Keyword(s):  
Large Scale ◽  
Objective Response ◽  
Evaluation Criteria ◽  
Progression Free Survival ◽  
The Other ◽  
Line Treatment ◽  
First Line ◽  
Platinum Based Chemotherapy ◽  
Nsclc Patients ◽  
First Line Treatment

e20527 Background:Platinum-based chemotherapy is the standard first-line treatment for non-squamous NSCLC patients without driver oncogene (EGFR, KRAS, and ALK mutations). However, it remains unknown that from which chemotherapy regimens can those patients get more benefit. Therefore, the study explore whether pemetrexed combined with platinum chemotherapy is superior to the other platinum-based chemotherapy regimens.Methods:We performed a retrospective study on 114 histologically or cytologically advanced IIIB-IV NSCLC patients admitted to Cancer Hospital from 1 Jan 2013 to 30 Dec 2015. The primary endpoint was the median progression free survival (PFS) and the disease control rate (DCR). And objective response was evaluated every two cycles by imaging according to the Response Evaluation Criteria In Solid Tumors (RECIST version 1.0). The multivariate logistic analyses were carried out by SPSS version 16.0. Results:114 patients received platinum-base doublet as first-line treatment. Among them, 59 patients underwent pemetrexed-containing regimens, and 55 patients received non-pemetrexed-containing regimens (38 patients for paclitaxel-containing regimens, 13 patients for gemcitabine-containing regimens, and 4 patients for other regimens.). The baseline characteristics between two groups were comparable ( p>0.05). The median PFS of pemetrexed-containing regimens was significantly longer compared with that of non-pemetrexed-containing regimens (7.2 months [95% CI: 5.3–9.1] vs. 4.9 months [95% CI: 3.2–6.6], p%0.05). DCR of pemetrexed-containing regimens was better than that of non-pemetrexed-containing regimens in the multivariate logistic analysis (89.8% vs.74.5%, p%0.05).Conclusions:Pemetrexed-containing regimens displayed more benefit than the other chemotherapy regimens for non-squamous NSCLC patients without driver oncogene. However, large scale perspective study is warranted in the future.

Sign in / Sign up

Export Citation Format

Share Document