scholarly journals Phase II randomized trial of a non-steroidal mouth wash for prevention and treatment of stomatitis in women with hormone receptor positive breast cancer treated with everolimus

2020 ◽  
Vol 12 ◽  
pp. 175883592096725
Author(s):  
Parvin F. Peddi ◽  
Merry Tetef ◽  
Paul Coluzzi ◽  
Karo K. Arzoo ◽  
Eddie H. Hu ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Randomized Trial ◽  
Phase Ii ◽  
Statistical Significance ◽  
Metastatic Breast ◽  
Average Score ◽  
Prophylactic Measure ◽  
The Difference ◽  
Mouth Wash

Background: Stomatitis is a frequent dose limiting toxicity of everolimus, an approved therapy for patients with metastatic breast cancer. No randomized trials of a prophylactic measure to prevent mucositis have been reported. Methods: We conducted a phase II, open-label trial in which patients with metastatic breast cancer starting everolimus were randomized to best supportive care (BSC) versus prophylactic use of an oral mucoadhesive, non-steroid containing mouth wash. The primary endpoint was rate of any grade stomatitis as reported by the treating physicians. Secondary endpoints were severity of stomatitis according to the Oral Mucositis Assessment Scale (OMAS) and rates of everolimus dose reduction or discontinuation due to mucositis. Results: Of 61 evaluable patients, 32 were randomized to and treated with oral mucoadhesive and 29 with BSC. Any grade stomatitis developed in 46.9% (15/32) of study arm and 65.5% (19/29) of BSC arm patients ( p = 0.14). The difference between the two arms was significantly in favor of the mucoadhesive arm when mucositis was scored according to the OMAS with average score of 0.3 in study arm versus 0.5 in the control arm ( p = 0.03). There were fewer dose adjustments or therapy discontinuations in the study arm compared with BSC (16% versus 31%, respectively) but the difference did not reach statistical significance. Conclusion: Here we provide early evidence from the first randomized trial supporting the use of oral prophylactic mucoadhesive for everolimus-associated stomatitis. A trial comparing prophylactic oral mucoadhesive to steroid mouth wash may be warranted.

Randomized, Placebo-Controlled, Double-Blind, Phase II Study of Axitinib Plus Docetaxel Versus Docetaxel Plus Placebo in Patients With Metastatic Breast Cancer

2011 ◽  
Vol 29 (18) ◽  
pp. 2459-2465 ◽  
Author(s):  
Hope S. Rugo ◽  
Alison T. Stopeck ◽  
Anil A. Joy ◽  
Stephen Chan ◽  
Shailendra Verma ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Adjuvant Chemotherapy ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Objective Response ◽  
Metastatic Breast ◽  
Double Blind ◽  
The Difference ◽  
To Receive

Purpose This multicenter, randomized, double-blind, phase II study assessed safety and efficacy of axitinib plus docetaxel in metastatic breast cancer (MBC). Patients and Methods Women with MBC were randomly assigned 2:1 to receive docetaxel 80 mg/m2 once every 3 weeks plus axitinib 5 mg twice per day (combination arm) or placebo (placebo arm), following a lead-in phase I trial. The primary end point was time to progression (TTP). Results In all, 168 patients were enrolled; 112 were randomly assigned to axitinib and 56 to placebo. Median TTP was numerically longer in the combination arm than in the placebo arm (8.1 v 7.1 months), but this difference was not statistically significant (hazard ratio, 1.24; 95% CI, 0.82 to 1.87; one-sided P = .156). The difference in median TTP was greatest among patients who had received prior adjuvant chemotherapy (9.2 v 7.0 months; P = .043, prespecified subgroup analysis). Objective response rate was higher in the combination arm (41.1% v 23.6%; P = .011). The most common grades 3 to 4 treatment-related adverse events (combination/placebo) included diarrhea (10.8%/0%), fatigue (10.8%/5.4%), stomatitis (12.6%/1.8%), mucositis (9.0%/0%), asthenia (7.2%/0%), and hypertension (4.5%/0%). Three patients in the combination arm experienced serious thromboembolic events (one death). Febrile neutropenia was more frequent in the combination arm (15.3% v 7.1%); rates of other hematologic toxicities were comparable. Increased toxicity with axitinib was generally managed by dose reduction and/or growth factor support. Conclusion The addition of axitinib to docetaxel did not improve TTP in first-line MBC treatment. Combination therapy may be more effective in patients previously exposed to adjuvant chemotherapy.

WJOG6110B (ELTOP): Randomized phase II trial comparing trastuzumab plus capecitabine (HX) and lapatinib plus capecitabine (LX) in HER2-positive metastatic breast cancer patients previously treated with trastuzumab and taxanes.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. TPS659-TPS659 ◽  
Author(s):  
Toshimi Takano ◽  
Hideharu Kimura ◽  
Kazuto Nishio ◽  
Takeharu Yamanaka ◽  
Yoshinori Ito ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Brain Metastases ◽  
Randomized Trial ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Metastatic Breast ◽  
Her2 Positive ◽  
Randomized Phase Ii ◽  
Previously Treated

TPS659 Background: In patients with HER2-positive metastatic breast cancer (MBC) previously treated with trastuzumab and taxanes, there are now two standard strategies: trastuzumab beyond progression or switch to lapatinib. A randomized trial comparing trastuzumab plus capecitabine (HX) and capecitabine alone (X) after first-line trastuzumab-based chemotherapy (GBG-26) showed that HX was superior to X in terms of time to progression (TTP). Another randomized trial comparing lapatinib plus capecitabine (LX) and X in patients previously treated with anthracyclines, taxanes, and trastuzumab (EGF100151) showed that LX was superior to X in terms of TTP. To evaluate which strategy is better, we are conducting an open-label, randomized phase II trial comparing HX and LX. Methods: Primary endpoint is progression-free survival, and secondary endpoints are overall response rate, overall survival, proportion of patients progressing brain metastases as site of first progression, and safety. Major eligibility criteria include: (1) HER2-positive MBC, (2) previously treated with taxanes, (3) disease progression or distant relapse while receiving trastuzumab, (4) previously untreated with capecitabine, S-1, and anti-HER2 drugs other than trastuzumab, (5) previously treated with no more than two chemotherapy regimens for MBC, (6) no symptomatic brain metastases (asymptomatic brain metastases are allowed), and (7) baseline left ventricular ejection fraction ≥50%. Patients in the HX arm receive capecitabine 2,500 mg/m2/day on days 1 to 14 plus trastuzumab (8 mg/kg loading dose and 6mg/kg thereafter) on day 1 every 3 weeks. Patients in the LX arm receive capecitabine 2,000 mg/m2/day on days 1 to 14 plus lapatinib 1250 mg/day on days 1 to 21 every 3weeks. Large-scale biomarker analyses are also performed to explore predictive factors of trastuzumab or lapatinib efficacy. We are investigating biomarkers related to HER family and other receptors, PI3K/Akt pathways, ligands, FcγR, circulating tumor cells, and so on. This study has just begun and 7 of planned 170 patients have been enrolled.

scholarly journals Quality of Life in a Randomized Phase II Study to Determine the Optimal Dose of 3-Week Cycle Nab-Paclitaxel in Patients with Metastatic Breast Cancer

2021 ◽  
Author(s):  
Naruto Taira ◽  
Kosuke Kashiwabara ◽  
Junji Tsurutani ◽  
Masahiro Kitada ◽  
Masato Takahashi ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Metastatic Breast Cancer ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Metastatic Breast ◽  
Optimal Dose ◽  
Randomized Phase Ii ◽  
The Difference

Abstract Purpose: To report our findings on quality of life (QoL) in a randomized phase II study to determine the optimal dose of 3-week cycle nab-paclitaxel (q3w nab-PTX) in patients with metastatic breast cancer (MBC).Materials and Methods: Patients with HER2-negative MBC were randomly assigned to three different doses of q3w nab-PTX (SD: 260 mg/m2 vs. MD: 220 mg/m2 vs. LD: 180 mg/m2). QoL was assessed at baseline and during the 2nd, 4th and 6th courses of treatment using the Functional Assessment of Cancer Therapy-Taxane (FACT-Taxane), Cancer Fatigue Scale (CFS) and EuroQol 5-Dimension (EQ-5D). Comparisons were performed with mixed-model repeated-measures (MMRM).Results: A total of 141 patients were enrolled in the parent study, and 136 (96%) (44, 45 and 47 in the SD, MD, and LD groups) were included in the analysis. MMRM analysis showed that the difference from the baseline FACT-Taxane trial outcome index at MD and LD were significantly higher than that at SD (MD vs. SD p<0.001, LD vs. SD p<0.001). Differences from baseline for FACT-Taxane total, physical and emotional well-being, and taxane subscale scores at MD and LD were also higher than at SD. The difference from baseline for the CFS score at LD was lower than at SD (p=0.013) and those for EQ-5D utility scores at MD and LD were higher than at SD (MD vs. SD p=0.011, LD vs. SD p<0.001). Conclusion: QoL of patients treated with 220 or 180 mg/m2 of q3w nab-PTX was significantly better than that of patients treated with 260mg/m2.

Sign in / Sign up

Export Citation Format

Share Document