Phase II study of capecitabine (X) as palliative treatment for patients (p) with squamous head and neck cancer (HNC) with locoregional and/or metastatic relapse after previous platinum-based treatment (PBT): An interim analysis

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 6074-6074
Author(s):  
J. Martínez-Trufero ◽  
D. Isla ◽  
J. C. Adansa ◽  
R. Hitt ◽  
J. J. Cruz
Keyword(s):  
Palliative Treatment ◽  
Lung Metastases ◽  
Treatment Options ◽  
Objective Response ◽  
Dose Intensity ◽  
Hematological Toxicity ◽  
Line Treatment ◽  
Metastatic Relapse ◽  
Previously Treated ◽  
Ecog Ps

6074 Background: PBT is the standard therapy for HNC and is widely used as first line treatment. Nevertheless the incidence of relapse remains still high. Therefore, new non-platinum drugs need to be asses as second line treatment options. Taking into account the results obtained with X in HNC, we proposed this study to evaluate activity and tolerability of X when used as palliative monotherapy for relapsed HNC p previously treated with PBT. Methods: Patients aged 18–75 years, ECOG PS 0–2, with advanced squamous HNC with locoregional and/or metastatic relapse previously treated with PBT and adequate bone marrow, renal and hepatic functions were included. X (1,250 mg/m2 BID) during 14 days was administered every 21 days, for at least 2 cycles. Objective response rate (ORR) was assessed according RECIST criteria and toxicity following NCI-CTC v2 criteria. Results: Sixteen patients with median age 57 years old, all of them male, ECOG 0/1 (33.3% / 66.7%) and with squamous HNC, were analyzed. Twelve p had local disease, 4 p adenopathies and 6 p lung metastases. Median time since HNC diagnosis was 30.4 months and since disease extension diagnosis, 1.8 months. All p received a total of 58 cycles of X (median 3, range 1–6) and the median relative dose intensity was 92%. Four p were not evaluable for response (1 is still on treatment; 3 died, 2 due to unknown reasons and 1 due to an infection). ORR was 16.7%.The median follow-up time was 3.3 months, median TTP was 4.2 months and median OS was 4.7 months. Hematological toxicity G3/4 was reported in 2 p. The only grade 4 non-hematological toxicity was dysphagia in 1 p; grade III toxicities were: asthenia (2 p), anorexia (1 p), dehydratation (1 p), diarrhea (1 p), mucositis (1 p), weight loss (1 p) and palmar-plantar erythrodysesthesia (1 p). The most common grade II toxicity was asthenia (2 p). Conclusions: Capecitabine seems to be an active, feasible and well tolerated palliative treatment for advanced HNC patients that have previously received platinum-based schedules. No significant financial relationships to disclose.

Phase II study of capecitabine as palliative treatment for patients (p) with squamous head and neck cancer (HNC) with locoregional and/or metastatic relapse after previous platinum-based treatment (PBT): Final results of Spanish Head and Neck Cancer Group (TTCC)

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 6047-6047 ◽  
Author(s):  
J. Martinez-Trufero ◽  
D. Isla ◽  
J. C. Adansa ◽  
A. Irigoyen ◽  
R. Hitt ◽  
...  
Keyword(s):  
Head And Neck Cancer ◽  
Head And Neck ◽  
Neck Cancer ◽  
Palliative Treatment ◽  
Objective Response ◽  
Hematological Toxicity ◽  
Line Treatment ◽  
Metastatic Relapse ◽  
Previously Treated ◽  
Ecog Ps

6047 Background: PBT is widely used as first line treatment in relapsed and/or metastatic HNC. Therefore, new non-platinum drugs need to be asses as second line treatment options. We proposed this study to evaluate activity and tolerability of capecitabine (X) when used as palliative monotherapy for relapsed HNC p previously treated with PBT. Methods: Forty patients (p) aged 18–75 years, ECOG PS 0–2, with advanced squamous HNC with locoregional and/or metastatic relapse previously treated with PBT and adequate bone marrow, renal and hepatic functions were included. X (1,250 mg/m2 BID) during 14 days was administered every 21 days, for at least 2 cycles. RECIST objective response rate (ORR) was assessed and toxicity following NCI-CTC v2 criteria. Results: Forty patients with median age 58 years old, all of them male, ECOG 0–2 (0:25%/1:70%/2:5%) and with squamous HNC, were analyzed. 34 p had local disease, 9 p regional disease and 19 p distant metastases(12 p lung). Median time since HNC diagnosis was 17.7 months and since disease extension diagnosis, 1.1 months. All p received a total of 169 cycles of X (median 4, range 1–9) and the median relative dose intensity was 91%. 7 p were not evaluable for response, since they do not receive at least 3 cycles ( 3 died, 2p due to toxicity, 2p due to decrease in ECOG PS ). ORR was 22.5 %.The median follow-up time was 5.2 months (alive p: 8.8 months), median TTP was 4.6 months and median OS was 6.2 months. Hematological toxicity G3/4 was reported in 6 p. 2p reported as grade 4 non-hematological toxicity: dysphagia and palmar-plantar erythrodysesthesia; grade III toxicities were: asthenia (4 p), anorexia (1 p), dehydratation (1 p), diarrhea (3 p), dysphagia (3 p) mucositis (4 p), weight loss (1 p), and palmar-plantar erythrodysesthesia (3 p). The most common grade II toxicity was asthenia (8 p). Conclusions: Capecitabine seems to be an active, feasible and well tolerated palliative treatment for advanced HNC patients that have previously received platinum-based schedules. No significant financial relationships to disclose.

Palbociclib (P) in patients (pts) with head and neck cancer (HNC) with CDKN2A loss or mutation: Results from the Targeted Agent and Profiling Utilization Registry (TAPUR) study.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 6043-6043
Author(s):  
Evan P. Pisick ◽  
Michael Rothe ◽  
Pam K. Mangat ◽  
Liz Garrett-Mayer ◽  
Francis P. Worden ◽  
...  
Keyword(s):  
Lung Metastases ◽  
Treatment Options ◽  
Objective Response ◽  
Progression Free Survival ◽  
Complete Response ◽  
Clinically Significant ◽  
Grade 3 ◽  
Ecog Ps ◽  
Stage 1 ◽  
Anti Tumor Activity

6043 Background: TAPUR is a phase II basket study evaluating anti-tumor activity of commercially available targeted agents in pts with advanced cancers with genomic alterations. Results in a cohort of HNC pts with CDKN2A loss or mutation treated with P are reported. Methods: Eligible pts had advanced HNC, no standard treatment options, measurable disease, ECOG PS 0-2, and adequate organ function. Genomic testing was performed in CLIA-certified, CAP-accredited site selected labs. Pts received P at 125 mg orally once daily for 21 days, followed by 7 days off until disease progression. Pts matched to P had CDKN2A loss or mutation and no RB mutations. Simon 2-stage design tested the null disease control (DC) - defined as partial (PR), complete response (CR) or stable disease at 16+ weeks (SD 16+) - rate of 15% vs. 35% (power = 0.85; α = 0.10). If ≥2 of 10 pts in stage 1 have DC, 18 more pts are enrolled. If ≥7 of 28 pts have DC, the null DC rate is rejected. Secondary endpoints are progression-free survival (PFS), overall survival (OS) and safety. Results: 28 pts (64% male) with HNC with CDKN2A loss (20 pts) or mutation (8 pts) were enrolled from June 2016 to Sept 2019. All were eligible for efficacy and toxicity. Demographics and outcomes are summarized in Table. No objective response (OR) and 10 pts with SD16+ (9 with CDKN2A loss, 1 with mutation) were observed for a DC rate of 37% (95% CI: 21%, 50%); the null DC rate of 15% was rejected (p=0.005). 14 pts had at least one grade 3-5 adverse or serious adverse event (AE/SAE) at least possibly related to P with the most common being low WBC/platelets. Other grade 3-4 AEs included anemia, fatigue, hypocalcemia, and syncope. There was one pt with grade 5 respiratory failure likely due to extensive lung metastases and aspiration but P-related pneumonitis could not be ruled out. Conclusions: Monotherapy P demonstrated modest anti-tumor activity and clinically significant AEs in heavily pre-treated pts with HNC with CDKN2A loss or mutation. Additional study is warranted to confirm the efficacy of P in pts with HNC with CDKN2A loss or mutation. Clinical trial information: NCT02693535. [Table: see text]

Endometriumkarzinom: Kombination aus Lenvatinib und Pembrolizumab zeigt Wirksamkeit unabhängig vom Mikrosatellitenstatus

2021 ◽  
pp. 1-2
Author(s):  
Sarah Matz
Keyword(s):  
Endometrial Carcinoma ◽  
Treatment Options ◽  
Objective Response ◽  
Progression Free Survival ◽  
Efficacy Analysis ◽  
Duration Of Response ◽  
Previously Treated Patients ◽  
Previously Treated ◽  
Prior Systemic Therapy ◽  
Grade 3

<b>Purpose:</b> Patients with advanced endometrial carcinoma have limited treatment options. We report final primary efficacy analysis results for a patient cohort with advanced endometrial carcinoma receiving lenvatinib plus pembrolizumab in an ongoing phase Ib/II study of selected solid tumors. <b>Methods:</b> Patients took lenvatinib 20 mg once daily orally plus pembrolizumab 200 mg intravenously once every 3 weeks, in 3-week cycles. The primary end point was objective response rate (ORR) at 24 weeks (ORRWk24); secondary efficacy end points included duration of response (DOR), progression-free survival (PFS), and overall survival (OS). Tumor assessments were evaluated by investigators per immune-related RECIST. <b>Results:</b> At data cutoff, 108 patients with previously treated endometrial carcinoma were enrolled, with a median follow-up of 18.7 months. The ORRWk24 was 38.0% (95% CI, 28.8% to 47.8%). Among subgroups, the ORRWk24 (95% CI) was 63.6% (30.8% to 89.1%) in patients with microsatellite instability (MSI)-high tumors (n = 11) and 36.2% (26.5% to 46.7%) in patients with microsatellite-stable tumors (n = 94). For previously treated patients, regardless of tumor MSI status, the median DOR was 21.2 months (95% CI, 7.6 months to not estimable), median PFS was 7.4 months (95% CI, 5.3 to 8.7 months), and median OS was 16.7 months (15.0 months to not estimable). Grade 3 or 4 treatment-related adverse events occurred in 83/124 (66.9%) patients. <b>Conclusion:</b> Lenvatinib plus pembrolizumab showed promising antitumor activity in patients with advanced endometrial carcinoma who have experienced disease progression after prior systemic therapy, regardless of tumor MSI status. The combination therapy had a manageable toxicity profile. <b>Trial registration:</b> ClinicalTrials.gov NCT02501096.

Palbociclib (P) in patients (pts) with soft tissue sarcoma (STS) with CDK4 amplification: Results from the Targeted Agent and Profiling Utilization Registry (TAPUR) study.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 11565-11565
Author(s):  
Scott Schuetze ◽  
Michael Rothe ◽  
Pam K. Mangat ◽  
Liz Garrett-Mayer ◽  
Funda Meric-Bernstam ◽  
...  
Keyword(s):  
Treatment Options ◽  
Objective Response ◽  
Progression Free Survival ◽  
Complete Response ◽  
Stage Design ◽  
Secondary Endpoints ◽  
Grade 3 ◽  
Ecog Ps ◽  
Stage 1 ◽  
Anti Tumor Activity

11565 Background: TAPUR is a phase II basket study evaluating anti-tumor activity of commercially available targeted agents in pts with advanced cancers with genomic alterations. Results in a cohort of STS pts with CDK4 amplification treated with P are reported. Methods: Eligible pts had advanced STS, no standard treatment options, measurable disease, ECOG PS 0-2, and adequate organ function. Genomic testing was performed in CLIA-certified, CAP-accredited site selected labs. Pts received P at 125 mg orally once daily for 21 days, followed by 7 days off until disease progression. Pts matched to P had CDK4 amplification and no RB mutations. Simon 2-stage design tested the null disease control (DC) - defined as partial (PR), complete response (CR) or stable disease at 16+ weeks (SD 16+) - rate of 15% vs. 35% (power = 0.85; α = 0.10). If ≥2 of 10 pts in stage 1 have DC, 18 more pts are enrolled. If ≥7 of 28 pts have DC, the null DC rate is rejected. Secondary endpoints are progression-free survival (PFS), overall survival (OS) and safety. Results: 29 pts (66% male) with STS with CDK4 amplification were enrolled from July 2016 to Nov 2019. 1 pt was not evaluable and excluded from efficacy analyses. Demographics and outcomes are summarized in Table. One pt with partial response (PR) and 12 pts with SD16+ were observed for DC and objective response (OR) rates of 48% (95% CI: 31%, 62%) and 3.7% (95% CI: 0.1%, 19%), respectively, and the null DC rate of 15% was rejected (p<0.001). 9/13 pts with DC continued on treatment for >32 weeks. 14 pts had at least one grade 3-4 AE at least possibly related to P with the most common being low WBC/platelets. Other grade 3 AEs included increased alanine aminotransferase, anemia, and fatigue. Conclusions: Monotherapy P demonstrated anti-tumor activity in heavily pre-treated pts with STS with CDK4 amplification. Additional study is warranted to confirm the efficacy of P in pts with STS with CDK4 amplification. Clinical trial information: NCT02693535. [Table: see text]

Abbreviated Treatment with Short-Course Dose-Adjusted EPOCH and Rituximab (DA-EPOCH-R) Is Highly Effective in AIDS-Related Lymphoma (ARL).

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 3111-3111 ◽  
Author(s):  
Kieron Dunleavy ◽  
Richard Little ◽  
Juan Gea-Banacloche ◽  
Nicole Grant ◽  
Seth Steinberg ◽  
...  
Keyword(s):  
Stage Iv ◽  
Dose Intensity ◽  
Cell Loss ◽  
Hematological Toxicity ◽  
Hiv Viral Load ◽  
Cd4 Cell Count ◽  
Short Course ◽  
Ecog Ps ◽  
Cd4 Cell

Abstract In ARL, rituximab may slightly improve CHOP response but is associated with greater toxicity (Proc Am Soc Hem102:1488, 2003). We hypothesized that the addition of rituximab to DA-EPOCH may increase fractional tumor cell kill and allow fewer treatment cycles and lower immune suppression. Patients received DA-EPOCH-R (E=etoposide 50 mg/m2/d, O=vincristine 0.4 mg/m2/d and H=doxorubicin 10 mg/m2/d all CIV d 1–4 (96 hours); C=cyclophosphamide 750 mg/m2 IV d5; P=prednisone 60 mg/m2 PO qd d1–5 and R=rituximab 375 mg/m2 IV d1 and 5) with G-CSF. Prophylactic IT MTX x 6 was administered. HAART was discontinued before and recommenced after DA-EPOCH-R. Unlike our previous study of DA-EPOCH in ARL (BLOOD101:4653, 2003) where the dose of C was lower and based on CD4 cell count, all patients on this study received full dose C on cycle 1 with subsequent reduction if the ANC nadir was < 500/mm3 for ≥ 2 days. Patients received 1 cycle beyond CR, based on CT and PET, for a minimum of 3 cycles. Characteristics of 21 patients include median (range) age 39 (9–61) years; IPI 3 (0–4); ECOG PS 2 (1–4); CD4 212 (0–674) cells/mm3 and HIV viral load 53100 (0– 286472) RNA copies/mL. Additionally, male sex 17 (81%); LDH> nl 15 (71); stage IV 15 (71%) and histology with diffuse large B-cell 9 (90%) and Burkitt’s lymphoma 2 (10%). The 18 patients who completed treatment (2 TE; 1 NE) received a median (range) of 3 (3–5) cycles. Responses are CR/CRu 15 (83%); PR 1 (6%) and NR 2 (11%). At 19 mos median follow-up, overall PFS and OS are both 77%, and both 90% in patients with CD4 > 100 cells/mm3. Treatment outcome of DA-EPOCH-R is similar to DA-EPOCH (CR 74% and PFS 73% at 53 months) but with significantly shorter treatment (median cycles 3 vs. 6). Toxicity on 57 cycles include ANC < 500/mm3 on 27 (47%); platelets < 50,000/mm3 on 15 (26%) and; fever/neutropenia on 20 (35%) cycles. DA-EPOCH-R produced a median (range) CD4 cell decrement of 64 (−541 to + 239) cells/mm3 compared to 189 (−973 to +19) with DA-EPOCH. Hematological toxicity is higher with DA-EPOCH-R compared to DA-EPOCH with ANC < 500/mm3 47% vs 30% and fever/neutropenia 35% vs. 13%, respectively, likely due to higher C dose intensity and/or rituximab. Other toxicities are similar. Abbreviated DA-EPOCH-R is equivalent to DA-EPOCH x 6 and appears to produce less CD4 cell loss. Accrual continues. Figure Figure

High efficacy and low toxicity of the combination of vinorelbine and capecitabine as second line treatment in metastatic breast cancer previously treated with taxanes and/or anthracyclines

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 10719-10719 ◽  
Author(s):  
G. Orphanos ◽  
A. Alexopoulos ◽  
G. Ioannidis ◽  
C. Kandylis ◽  
A. Ardavanis ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Single Agent ◽  
Metastatic Breast ◽  
Line Treatment ◽  
Second Line ◽  
Previously Treated ◽  
Statistical Planning ◽  
Metastatic Sites ◽  
Ecog Ps

10719 Background: Capecitabine and Vinorelbine have shown considerable activity given as single agent or in combination with other drugs. The aim of this single institution ph.II study is to evaluate the response to the combination of Capecitabine and Vinorelbine given as second line treatment in patients with metastatic breast cancer previously treated with taxanes and/or anthracyclines. Methods: The regimen consists of Capecitabine 2000 mg/m2 D1-D14 and Vinorelbine 20 mg/m2 D1,D8 q 3 weeks for six cycles. Evaluation of response was accomplished with CT scan after the third and sixth cycle. Patients with disease progression after cycle 3 are taken off protocol. Patients with gr 2/3 granulocytopenia are given G-CSF for all subsequent cycles and there is a 20% dose reduction in both drugs for patients with gr 4 granulocytopenia. Results: 30 pts have been enrolled so far; according to statistical planning the total number of accrued pts should reach 63. Median age 55 yrs (30–76), median ECOG PS 1 (0–2), pre/postmenopausal 6/24. Number of metastatic sites: 1 in 6 pts, 2 in 15 pts, 3 in 6 pts and 4 in 3 pts. A total of 146 cycles was administered. Overall response rate 50% with CR in 2 (6.7%) pts, PR in 13 (43.3%) pts. Stable disease was observed in 4 (13.3%) pts, 8 (26.6%) pts had progressive disease and 3 (10%) were non evaluable. Toxicity: anemia gr 2 in 2 (6.7%) pts and gr 3 in 1 (3.3%) ptn, thrombocytopenia gr2 in 2 (6.7%) pts, granulocytopenia gr 2/3 in 17 (56.7%) pts and gr4 in 1 (3.3%) ptn. Gr 1/2 nausea or vomiting was observed in 5 (16.6%) pts and gr 3/4 in 2 (6.7%) pts. Vinorelbine induced phlebitis in 3 (10%) pts, gr1/2 diarrhea in 3 (10%) and fungal infection of the nail beds in 2 (6.7%) pts. Conclusions: Preleminary results suggest that the Capecitabine and Vinorelbine combination is an active and safe regimen for second line metastatic breast cancer treatment. The study remains open to achieve the planned patient accrual. No significant financial relationships to disclose.

Gemcitabine (GEM) (day 1–8) plus carboplatin (CBDCA) (day 2) for the treatment of advanced non-small cell lung cancer (aNSCLC) in elderly or poor performance status (PS) patients (pts)

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 18116-18116
Author(s):  
F. Sperandi ◽  
B. Melotti ◽  
A. A. Martoni
Keyword(s):  
Overall Survival ◽  
Performance Status ◽  
Objective Response ◽  
Haematological Toxicity ◽  
Dose Intensity ◽  
Poor Performance ◽  
Primary Objective ◽  
Hematological Toxicity ◽  
Poor Performance Status ◽  
Histologic Subtype

18116 Background: Several studies have demonstrated that the combination of CBDCA plus GEM according to various regimens appears as effective as cisplatin (CP) containing regimens. CBDCA plus GEM regimens are associated with more haematological toxicity (G3–4 leucopenia 17–40.6%, G3–4 neutropenia 29–75%, G3–4 thrombocytopenia 21–57% and G3–4 anaemia 5–33%), but with lower non-hematological toxicity as compared to CP-based regimens. Methods: The primary objective of this trial was the evaluation of the overall survival, while the secondary objectives were assessment of objective response and toxicity in elderly or poor PS pts. The eligible pts had previously untreated aNSCLC not suitable for CP-based chemotherapy. Pts received each at 3-week intervals GEM 1000 mg/sq on day 1 and 8 plus CBDCA area under the curve of 5 on day 2. Between April 2004 and January 2007, 54 consecutive pts were accrued in the study. Pt characteristics were: 42 (78%) males and 12 (22%) females; median age 72 years (range: 56–84 years) with 67% of pts = 70 years; median Karnofsky PS 90 (range: 50–100) with 33% of pts = 80; stage disease: IIB not suitable for surgery in 1 (2%) pt, IIIA in 5 (9%), IIIB in 10 (19%), IV in 33 (61%) and recurrent disease in 5 (9%); histologic subtype: adenocarcinoma in 30 (56%) pts, epidermoid in 11 (20%), bronchioalveolar carcinoma in 2 (4%) and other histologic subtypes in 11 (20%). Results: A median of 4 courses was administered (range 1–8). Dose- intensity was 98.7% (range 50–100%) for CBDCA and 87.2% (range 60–100%) for GEM. Objective response according to intention-to-treat analysis was as follows: 15 (28%) pts had PR, 16 (29%) had SD, 14 (27%) had PD and 9 (16%) were not assessable because lost to follow-up or too early. Median overall survival was 10 months. WHO G3 leucopenia was observed in 5 (9%) pts, G3–4 neutropenia in 15 (28%), G3 thrombocytopenia in 7 (13%) and G3 anaemia in 2 (4%). No WHO G3–4 non-hematological toxicity was observed. Conclusions: This regimen is feasible and active in elderly or poor PS pts. It can be administered in a outpatient setting because toxicity is moderate and manageable. No significant financial relationships to disclose.

The association of objective response and overall survival in patients with inoperable or metastatic gastric and esophagogastric junction (EGJ) cancer: A pooled analysis of individual patient data from first-line clinical trials.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 4095-4095
Author(s):  
Toki Anna Bolt ◽  
Claudia Pauligk ◽  
Dominique Werner ◽  
Frank Mayer ◽  
Ralf Dieter Hofheinz ◽  
...  
Keyword(s):  
Overall Survival ◽  
Survival Data ◽  
Lung Metastases ◽  
Objective Response ◽  
Surrogate Marker ◽  
Pooled Analysis ◽  
Survival Times ◽  
First Line ◽  
Regional Lymph Nodes ◽  
Ecog Ps

4095 Background: The aim of the study is to determine whether the achievement of an objective response to first-line chemotherapy is prognostic of patient’s outcome in gastric/EGJ adenocarcinoma. Methods: Individual patient (pts) data from prospective first-line trials conducted by a single study group were used. Patients received platin/5-FU based chemotherapy with or without docetaxel. Responses were evaluated according to WHO criteria in all trials. Response data, patients’ characteristics (age, sex, entity, histological type, primary location, ECOG PS, and type and number of metastatic sites), type of chemotherapy, and overall survival data were analyzed. Results: 612 pts were included. Median age was 66 yrs; 31.5% had ECOG status 0, 58.3% ECOG 1, and 9.8% ECOG 2 & 3. Gastric primaries were found in 44.4% and EGJ in 35.8% of pts (19.7% were overlapping/not evaluable). According to Lauren classification, 36.8% had intestinal, 32.4% diffuse, and 8.5% mixed types (22.4% were not classifiable). 64.5% had positive non-regional lymph nodes (LN) involvement, 14.1% LN involvement without other metastases, 33.3% had peritoneal carcinomatosis, 44.0% liver and 16.7% lung metastases. Response rates were complete (CR) in 3.1%, partial (PR) in 36.4%, stable disease (SD) in 34.5%, and progressive disease (PD) in 15.0% pts (10.9% were not evaluable). Overall response rate (OR; CR + PR) was 39.5%. Median overall survival times in pts with CR vs PR vs SD vs PD were 37.9 vs 14.7 vs 10.9 vs 5.2 months, respectively; p=1.26 x 10-33). OR (CR or PR) also strongly predicted OS (16.7 vs 8.1 months in pts with vs no OR, p=1.08 x 10-17). OR remained the strongest predictor of OS in the multivariate analysis (p=6.55 x 10-7) including all baseline criteria mentioned above followed by ECOG PS (p=0.048) and the presence of non-regional LN as the only site of metastasis (p=0.034). Conclusions: The achievement of an objective response is the strongest predictor of survival in pts with gastric and EGJ cancer and could serve as a surrogate marker if validated.

A phase II trial of salvage treatment with gemcitabine and S-1 combination in heavily pretreated patients with metastatic colorectal cancer.

2013 ◽  
Vol 31 (4_suppl) ◽  
pp. 488-488 ◽  
Author(s):  
Sun Jin Sym ◽  
Junshik Hong ◽  
Hee Kyung Ahn ◽  
Jinny Park ◽  
Eun Kyung Cho ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Disease Control ◽  
Metastatic Colorectal Cancer ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Treatment Options ◽  
Objective Response ◽  
Progression Free Survival ◽  
Median Number ◽  
Ecog Ps

488 Background: We conducted a phase II trial of gemcitabine with S-1 to evaluate the activity and toxicity of such a combination in heavily pre-treated patients (pts) with metastatic colorectal cancer (mCRC) who have progressed after treatment with 5-fluorouracil (5-FU), oxaliplatin and irinotecan. Methods: 34 pts were enrolled, with the following characteristics: 17 (50%) females, median age 57 years (28-72), 28 (82%) ECOG PS 0-1. S-1 was given orally (30 mg/m2) b.i.d for 14 consecutive days and gemcitabine (1000 mg/m2) was given on days 1 and 8, every 21 days, until disease progression and for a maximum of 9 cycles. The primary endpoint was objective response rate (ORR). Results: The median number of cycles was four (range 1-9). ORR was 14.7% (95% confidence interval [CI] 2.8-26.6) and disease control rate was 58.8% (95% CI 42.2-75.3) with five partial responses and fifteen stable diseases. Median duration of disease control was 5.1 months (95% CI 3.3-7.0). Median progression-free survival was 3.2 months (95% CI 2.3-4.1) and median overall survival was 11.8 months (95% CI 7.0-16.5). Grade 3-4 toxicities were neutropenia (12%), anemia (12%), thrombocytopenia (3%) and diarrhea (3%). Conclusions: Combination chemotherapy with gemcitabine and S-1 was well tolerated and efficacious for heavily pre-treated mCRC pts, and could be an alternative for pts with good PS but no further treatment options.

Atezolizumab (atezo) in patients with metastatic urothelial carcinoma (mUC): A 2-year clinical update from a phase Ia study.

2017 ◽  
Vol 35 (6_suppl) ◽  
pp. 290-290 ◽  
Author(s):  
Daniel Peter Petrylak ◽  
Thomas Powles ◽  
Joaquim Bellmunt ◽  
Fadi S. Braiteh ◽  
Yohann Loriot ◽  
...  
Keyword(s):  
Objective Response ◽  
The United States ◽  
Term Treatment ◽  
Long Term Results ◽  
Platinum Based Chemotherapy ◽  
Long Term Treatment ◽  
Previously Treated ◽  
Ecog Ps

290 Background: Atezo (anti–PD-L1) has demonstrated safety and efficacy in a broad range of cancers and is approved in the United States for mUC previously treated with platinum-based chemotherapy. Here we report long-term results in mUC from Phase Ia study NCT01375842 (PCD4989g). Methods: Previously treated mUC patients received atezo 15 mg/kg or 1200 mg IV q3w. Enrollment in this Phase Ia expansion cohort initially required PD-L1–selected status and later opened to patients regardless of PD-L1 expression on tumor-infiltrating immune cells. The primary endpoint was safety/tolerability. Secondary endpoints included investigator-assessed RECIST v1.1 ORR (confirmed), DOR and OS. Results: 95 patients were safety evaluable (Table). Median age was 66 years, 76% were male and 80% had primary bladder tumors. 61% had ECOG PS 1. 52% received ≥ 3 prior systemic therapies for mUC (70% platinum). Median treatment duration was 3 months (range: 0-32 months); 24% were treated for ≥ 1 year. Treatment-related AEs occurred in 66% (all Grade) and 8% (Grade 3-4) of patients. No treatment-related deaths were reported. In 94 objective response–evaluable patients (follow-up ≥ 12 weeks), the ORR was 27% (95% CI: 18, 37%), and the CR rate was 10%; the SD rate was 19%. mDOR was 22.1 months (95% CI: 12.1, NE months) in all patients; 56% of responses (7/9 CRs and 7/16 PRs) were ongoing at the December 15, 2015 data cutoff. With a 24-month median follow-up duration (range: 1+ to 32 months), the 1-year OS rate was 47% (95% CI: 36, 58%), and the 2-year rate was 29% (19, 40%); mOS is in the Table. Updated clinical data with further follow-up and analyses by PD-L1 status will be presented. Conclusions: Long-term treatment with atezo was well tolerated, without new safety signals in heavily pre-treated mUC patients. The durability of responses, including CRs, along with extended OS, confirm atezo as a new standard for previously treated mUC patients. Clinical trial information: NCT01375842. [Table: see text]

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