Prospective Exploratory Analysis of the Association Between Tumor Response, Quality of Life, and Expenditures Among Patients Receiving Paclitaxel Monotherapy for Refractory Metastatic Breast Cancer

2002 ◽  
Vol 20 (17) ◽  
pp. 3665-3673 ◽  
Author(s):  
Shanu Modi ◽  
Katherine S. Panageas ◽  
Elaine T. Duck ◽  
Ariadne Bach ◽  
Nancy Weinstock ◽  
...  

PURPOSE: To prospectively evaluate the association between tumor response, change in quality of life (QoL), and hospital expenditures in patients with metastatic breast cancer (MBC) receiving single-agent paclitaxel. PATIENTS AND METHODS: Eligible patients had bidimensionally measurable MBC and any number of previous therapies, excluding taxane chemotherapy. Paclitaxel was administered by various different infusion schedules. QoL measures were evaluated for each patient at baseline and serially using the Memorial Symptom Assessment Scale (MSAS)-Global Distress Index (GDI) and Functional Assessment of Cancer Therapy–Breast (FACT-B) instruments. Patients were assessed for early (first 6 weeks) and ever changes in QoL parameters. Charges were monitored through the hospital’s centralized computer billing system and converted to cost ratios for the analysis. Correlations between response and improvement in QoL were assessed by Fisher’s exact test statistic. Associations between improvements in QoL with cost ratios were assessed by logistic regression and likewise between response and cost ratios. RESULTS: Of the 59 patients treated, 50 had sufficient data for comparative analyses. The overall response rate was 24% (all partial responses). Minor responses were observed in 17% of patients, 25% had stable disease, and 29% had progression. Responding patients had significant improvement in QoL as assessed by MSAS-GDI (P = .004) and FACT-B (P = .028). The mean total cost/month ratios for patients experiencing improved GDI QoL scores was 1.31 versus 1.56 for those without QoL benefit (P = .52) and 1.05 versus 1.76 for responders versus nonresponders, respectively (P = .07). CONCLUSION: Patients with evidence of tumor response on paclitaxel had a QoL benefit not observed in nonresponders, and this response was associated with a trend for lower overall costs.

2003 ◽  
Vol 21 (4) ◽  
pp. 588-592 ◽  
Author(s):  
George W. Sledge ◽  
Donna Neuberg ◽  
Patricia Bernardo ◽  
James N. Ingle ◽  
Silvana Martino ◽  
...  

Purpose: Between February 1993 and September 1995, 739 patients with metastatic breast cancer were entered on an Intergroup trial (E1193) comparing doxorubicin (60 mg/m2), paclitaxel (175 mg/m2/24 h), and the combination of doxorubicin and paclitaxel (AT, 50 mg/m2 and 150 mg/m2/24 h, plus granulocyte colony-stimulating factor 5 mg/kg) as first-line therapy. Patients receiving single-agent doxorubicin or paclitaxel were crossed over to the other agent at time of progression. Patients and Methods: Patients were well balanced for on-study characteristics. Results: Responses (complete response and partial response) were seen in 36% of doxorubicin, 34% of paclitaxel, and 47% of AT patients (P = .84 for doxorubicin v paclitaxel, P = .007 for v AT, P = .004 for paclitaxel v AT). Median time to treatment failure (TTF) is 5.8, 6.0, and 8.0 months for doxorubicin, paclitaxel, and AT, respectively (P = .68 for doxorubicin v paclitaxel, P = .003 for doxorubicin v AT, P = .009 for paclitaxel v AT). Median survivals are 18.9 months for patients taking doxorubicin, 22.2 months for patients taking paclitaxel, and 22.0 months for patients taking AT (P = not significant). Responses were seen in 20% of patients crossing from doxorubicin → paclitaxel and 22% of patients crossing from paclitaxel → doxorubicin (P = not significant). Changes in global quality-of-life measurements from on-study to week 16 were similar in all three groups. Conclusion: (1) doxorubicin and paclitaxel, in the doses used here, have equivalent activity; (2) the combination of AT results in superior overall response rates and time to TTF; and (3) despite these results, combination therapy with AT did not improve either survival or quality of life compared to sequential single-agent therapy.


2011 ◽  
Vol 22 (12) ◽  
pp. 2582-2590 ◽  
Author(s):  
Y. Wu ◽  
M.M. Amonkar ◽  
B.H. Sherrill ◽  
J. O’Shaughnessy ◽  
C. Ellis ◽  
...  

1998 ◽  
Vol 16 (10) ◽  
pp. 3439-3460 ◽  
Author(s):  
R Fossati ◽  
C Confalonieri ◽  
V Torri ◽  
E Ghislandi ◽  
A Penna ◽  
...  

PURPOSE A systematic review of randomized clinical trials (RCTs) was undertaken to assess the effectiveness of medical treatment for metastatic breast cancer. METHODS RCTs published between 1975 and 1997 have been classified according to 12 therapeutic comparisons: (1) polychemotherapy (PCHT) agents versus single agent; (2) PCHT regimens with anthracycline versus PCHT without anthracycline; (3) other PCHT versus cyclophosphamide, methotrexate, and fluorouracil (CMF); (4) chemotherapy (CHT) with epirubicin versus CHT with doxorubicin; (5) CHT versus same CHT delivered with less intensive schedules; (6) other endocrine therapy (OET) versus tamoxifen; (7) OET plus tamoxifen versus tamoxifen alone; (8) OET versus medroxyprogesterone; (9) OET versus aromatase inhibitors; (10) OET versus megestrol; (11) endocrine therapy (ET) versus same ET at lower doses; and (12) CHT plus ET versus CHT. Tumor response rates, mortality hazards ratio (HR) and frequency of severe side effects were the outcome measures. RESULTS A total of 189 eligible trials (31,510 patients) were identified. All provided response rates and 133 (70%) data or survival curves needed for calculation of the HR. In eight of 12 comparisons, statistically significant differences for response emerged (1, 2, 3, 5, 7, 8, 11, 12); all but no. 8 favored the first term of the comparison. Overall survival analysis showed better results of (a) PCHT versus single-agent CHT (HR=0.82; 95% confidence interval [CI], 0.75 to 0.90); (b) CHT with doxorubicin versus CHT with epirubicin (HR=1.13; 95% CI, 1.00 to 1.27); (c) CHT versus the same CHT delivered with less intensive schedules (HR=0.90; 95% CI, 0.83 to 0.97); (d) ET versus the same ET at lower doses (HR=0.86; 95% CI, 0.77 to 0.97). Quality of life was measured in only 2,995 of 31,510 patients (9.5%). CONCLUSION Despite some evidence of effectiveness of specific regimens, the relevance of these findings is limited by the modest survival benefit and the lack of evaluation of the quality-of-life impact of these treatments.


1999 ◽  
Vol 17 (8) ◽  
pp. 2355-2355 ◽  
Author(s):  
James F. Bishop ◽  
Joanna Dewar ◽  
Guy C. Toner ◽  
Jennifer Smith ◽  
Martin H.N. Tattersall ◽  
...  

PURPOSE: To determine the place of single-agent paclitaxel compared with nonanthracycline combination chemotherapy as front-line therapy in metastatic breast cancer. PATIENTS AND METHODS: Patients with previously untreated metastatic breast cancer were randomized to receive either paclitaxel 200 mg/m2 intravenously (IV) over 3 hours for eight cycles (24 weeks) or standard cyclophosphamide 100 mg/m2/d orally on days 1 to 14, methotrexate 40 mg/m2 IV on days 1 and 8, fluorouracil 600 mg/m2 IV on days 1 and 8, and prednisone 40 mg/m2/d orally on days 1 to 14 (CMFP) for six cycles (24 weeks) with epirubicin recommended as second-line therapy. RESULTS: A total of 209 eligible patients were randomized with a median survival duration of 17.3 months for paclitaxel and 13.9 months for CMFP. Multivariate analysis showed that patients who received paclitaxel survived significantly longer than those who received CMFP (P = .025). Paclitaxel produced significantly less severe leukopenia, thrombocytopenia, mucositis, documented infections (all P < .001), nausea or vomiting (P = .003), and fever without documented infection (P = .007), and less hospitalization for febrile neutropenia than did CMFP (P = .001). Alopecia, peripheral neuropathy, and myalgia or arthralgia were more severe with paclitaxel (all P < .0001). Overall, quality of life was similar for both treatments (P ≥ .07). CONCLUSION: Initial paclitaxel was associated with significantly less myelosuppression and fewer infections, with longer survival and similar quality of life and control of metastatic breast cancer compared with CMFP.


2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e12600-e12600
Author(s):  
Bruce A. Feinberg ◽  
Kevin Lord ◽  
Jonathan Kish ◽  
Jalyna R. Laney ◽  
Dhruv Chopra ◽  
...  

e12600 Background: Metastatic breast cancer (mBC) patients often receive multiple lines of systemic chemotherapy (Chemo) to extend life, manage disease symptoms and improve quality of life. Combination chemotherapy (cChemo) provides no survival advantage over single agent sequential chemotherapy (sasChemo) in mBC, but it may increase the risk of toxicity and adverse events while decreasing quality of life. The National Comprehensive Cancer Network guideline states that sasChemo is preferred for recurrent or stage IV mBC. This study aimed to explore adherence to this recommendation by evaluating contemporary real-world treatment patterns in mBC. Methods: Patients were identified from a third-party, administrative claims database. Using medical and pharmacy claims, any female with mBC (both BC and metastatic ICD9/10 codes) diagnosed between 01-Jan-2013 and 31-Dec-2017, followed for at least 6 months, and who had initiated systemic therapy was selected. Patients who received any HER2 targeted therapy, any oral or infused hormonal therapy, and/or had other malignant diagnoses were excluded. The proportion of patients receiving each line of chemotherapy was calculated in addition to the proportion of sasChemo and cChemo. Results: 10,342 patients met the selection criteria. Mean age at initiation of treatment was 61.7 years (SD = 12.12), 35.7% of patients had Medicare/Medicare advantage insurance coverage. All patients received first line (1L) systemic chemotherapy, 59% received 2L, 39% 3L, 25% 4L, 16% 5L, and 12% 6L respectively. 4 patients received ≥ 7L. The distribution between sasChemo vs cChemo was 50%/50% in 1L, 42%/58% 2L, 43%/57% in 3L, 44%/56% in 4L, 45%/55% in 5L and 46%/57% in 6L. Conclusions: Despite medical evidence which resulted in clinical guideline preference for sasChemo, cChemo use continues to have significant use in the salvage treatment of mBC. Research is warranted to understand and lessen this low value practice.


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