Patients' Utilities for Cancer Treatments

Objective. Temporary health states cannot be measured in the traditional way by means of techniques such as the time tradeoff (TTO) and the standard gamble (SG), where health states are chronic and are followed by death. Chained methods have been developed to solve this problem. This study assesses the feasibility of a chained TTO and a chained SG, and the consistency and concordance between the two meth ods. Patients and methods. Seventy female early-stage breast cancer patients were interviewed. In using both chained methods, the temporary health state to be evaluated was weighed indirectly with the aid of a temporary anchor health state. The patients were asked to evaluate their actual health states, a hypothetical radiotherapy scenario, and a hypothetical chemotherapy scenario. Results. Sixty-eight patients completed the interview. The use of the anchor health state yielded some problems. A significant difference between the means of the TTO and the SG was found for the anchor health state only. For the other health states, the results were remarkably close, because the design avoided some of the bias effects in traditional measurements. Conclusion. The feasibility and the consistency of the chained procedure were satisfactory for both methods. The problems regarding the anchor health state can be solved by adapting the methods and by the use of a carefully chosen anchor health state. The chained method avoids biases present in the conventional method, and thereby the TTO and the SG may be reconciled. Moreover, there are several psychological advantages to the method, which makes it useful for diseases with uncertain prognoses. Key words: utility assessment; time tradeoff; standard gamble; breast cancer; chemotherapy; ra diotherapy. (Med Decis Making 1998;18:391-399)

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Adjuvant radiotherapy (RT) and trastuzumab in stage I-IIA breast cancer: Toxicity data from North Central Cancer Treatment Group Phase III trial N9831

Journal of Clinical Oncology ◽

10.1200/jco.2006.24.18_suppl.523 ◽

2006 ◽

Vol 24 (18_suppl) ◽

pp. 523-523 ◽

Cited By ~ 21

Author(s):

M. Y. Halyard ◽

T. M. Pisansky ◽

L. J. Solin ◽

L. B. Marks ◽

L. J. Pierce ◽

...

Keyword(s):

Breast Cancer ◽

Early Stage ◽

Phase Iii ◽

Breast Cancer Patients ◽

Cardiac Events ◽

Concurrent Administration ◽

Adjuvant Trastuzumab ◽

Her2 Breast Cancer ◽

Significant Difference

523 Background: Adjuvant trastuzumab (Herceptin [H]) with chemotherapy improves outcome in HER2+ breast cancer (BC). Preclinical studies suggest H may enhance RT. We herein assess if H given with adjuvant RT increases adverse events (AE) after breast conserving surgery or mastectomy. Methods: N9831 randomized 3505 women with pT1–3N1–2M0, pT2–3N0M0, or pT1cN0M0 (ER/PR negative) HER2+ BC to doxorubicin (A) and cyclophosphamide (C) followed by weekly paclitaxel (T), AC→T→H, or AC→TH→H. Post-lumpectomy breast ± nodal RT was recommended, as was post-mastectomy chest wall + nodal RT (>3 nodes +); internal mammary RT was prohibited. RT started within 5 weeks of completion of T and allowed concurrently with H. 2324 eligible patients were enrolled on study prior to April 25, 2004: 1460 patients receiving RT are available for analysis of RT-associated AEs. Also, 1286 patients on +H arms who completed T (908 +RT and 378 -RT) are available for analysis of clinical cardiac events (CE). Rates of RT-associated AEs were compared across treatment arms, and rates of CE were compared for +RT vs -RT patients within +H arms. All reported p-values are for chi-squared statistics. Results: With a median follow-up of 1.5 years, significant differences among arms in RT-associated AEs were not identified. No significant differences across arms in +RT patients existed in the incidence of skin reaction (p=0.78), pneumonitis (p=0.78), dyspnea (p=0.87), cough (p=0.54), esophageal dysphagia (p=0.26), or neutropenia (p=0.16). There was a significant difference in +RT patients in the incidence of leukopenia (p=0.02) with higher incidence rates in the arms receiving H. RT did not increase the frequency of CE. In the AC→T→H arm, the incidence of CE was 2.2% in +RT patients versus 2.9% in -RT patients. In the AC→TH→H arm, the incidence of CE was 1.5% in +RT patients versus 6.3% in -RT patients. No difference in CE was seen between left- and right-sided RT fields in +RT patients in either +H arm. Conclusion: Concurrent administration of adjuvant RT with H in early stage breast cancer patients is not associated with an increased incidence of acute RT AEs. Further follow-up is required to assess late AEs. No significant financial relationships to disclose.

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Locoregional Relapse and Distant Metastasis in Conservatively Managed Triple Negative Early-Stage Breast Cancer

Journal of Clinical Oncology ◽

10.1200/jco.2006.06.5664 ◽

2006 ◽

Vol 24 (36) ◽

pp. 5652-5657 ◽

Cited By ~ 671

Author(s):

Bruce G. Haffty ◽

Qifeng Yang ◽

Michael Reiss ◽

Thomas Kearney ◽

Susan A. Higgins ◽

...

Keyword(s):

Breast Cancer ◽

Distant Metastasis ◽

Triple Negative ◽

Early Stage ◽

Prognostic Significance ◽

Conservative Surgery ◽

Hazard Ratio ◽

Breast Cancer Patients ◽

Locoregional Relapse ◽

Significant Difference

Purpose To determine the prognostic significance of triple negative breast cancers with respect to locoregional relapse and distant metastasis in conservatively managed breast cancer patients. Patients and Methods A database of conservative managed (conservative surgery followed by radiation) patients, in whom all three markers (estrogen receptor, progesterone receptor, and HER2/neu) were available, was reviewed. Patients were classified as triple negative if they tested negative for all three markers. Of 482 patients with all three markers available, 117 were classified as triple negative. Results As of September 2005, with a median follow-up time of 7.9 years, of the 482 patients in the study, there have been 53 in-breast relapses, 10 nodal relapses, 77 distant relapses, and 69 deaths. At 5 years, the triple negative cohort had a poorer distant metastasis-free rate compared with the other subtypes (67% v 82%, respectively; P = .002). Triple negative subtype was an independent predictor of distant metastasis (hazard ratio = 2.14; 95% CI, 1.31 to 3.53; P = .002) and cause-specific survival (hazard ratio = 1.79; 95% CI, 1.03 to 3.22; P = .047). There was no significant difference in local control between the triple negative and other subtypes (83% v 83%, respectively). Of 99 BRCA-tested patients in this cohort, 10 had deleterious mutations in BRCA1, and seven had mutations in BRCA2. Of 10 BRCA1 patients, eight were triple negative, whereas only one of seven BRCA2 patients was triple negative (P < .001). Conclusion Patients classified as triple negative have a poor prognosis. However, there was no evidence that these patients are at higher risk for local relapse after conservative surgery and radiation. Patients with BRCA1 mutations develop predominantly triple negative tumors.

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ALGA: A cancer patient profiling tool to improve physician-patient communication—An analysis in breast cancer patients.

Journal of Clinical Oncology ◽

10.1200/jco.2013.31.15_suppl.9582 ◽

2013 ◽

Vol 31 (15_suppl) ◽

pp. 9582-9582

Author(s):

Gabriella Pravettoni ◽

Sara Gandini ◽

Giuseppe Curigliano ◽

Alessandra Gorini ◽

Ketti Mazzocco ◽

...

Keyword(s):

Breast Cancer ◽

Personalised Medicine ◽

Healthy People ◽

Psychological Status ◽

Health State ◽

Breast Cancer Patients ◽

Positive Health ◽

Management Options ◽

Healthy Women ◽

Significant Difference

9582 Background: Considerable improvement of communication between physicians and patients (pts) will need to occur as personalised medicine becomes the norm. An accurate profile of the pt’s cognitive and psychological status should help the physician shape his language and his messages to maximise the pt’s understanding of her management options. To this aim a computerized tool (ALGA questionnaire) has been created and validated. Methods: The validation process produced a questionnaire with 4 main factors: Health State Perception, Psychological, Psychosocial and Cognitive aspects. To test its ability to discriminate between healthy people and pts, ALGA has been administered to 50 newly diagnosed primary Breast Cancer (BC) pts prior to their first visit with the oncologist to discuss their adjuvant treatment, and to 50 healthy women (age range:20-60), using an iPad. Results: A multivariate analysis showed a significant difference between BC pts and healthy women relatively to the four aforementioned broad areas: Psychosocial (F(1,56)=13.42, p<.001), Cognitive (F(1,56)=6.53, p<.01), and Psychological Aspect (F(1,56)=2.77, p=.05). ALGA detected pts with higher levels of anxiety and depression. Pts tended to ruminate more than healthy subjects. Finally, pts showed higher level of positive Health State Perception, suggesting a dissociation between cancer illness and general health. Cognitive and Psychological aspects and Health State Perception interacted with participants’ level of education (respectively: F(1,56)=12.23, p<.001; F(1,56)=4.58, p<.05; F(1,56)=7.9, p<.05). Starting from this results a personal profile for each pt was created. Conclusions: The ALGA confirmed ability to discriminate between healthy people and BC pts, and is a good tool to create a personal pt’s profile with which physicians can empower patient with tailored knowledge. Starting from ALGA questionnaire, a smart environment is being implemented as a decision support infrastructure to help communication, interaction and information delivery process from doctor to patient, influencing patient’s quality of life and satisfaction.

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Taxane-based adjuvant chemotherapy in node positive, early stage Turkish breast cancer patients

Open Medicine ◽

10.2478/s11536-009-0075-9 ◽

2009 ◽

Vol 4 (4) ◽

pp. 454-458

Author(s):

Ahmet Alacacioglu ◽

Baha Zengel ◽

Ali Denecli

Keyword(s):

Breast Cancer ◽

Adjuvant Chemotherapy ◽

Cancer Patients ◽

Early Stage ◽

Disease Free Survival ◽

Breast Cancer Patients ◽

Free Survival ◽

Node Positive ◽

Significant Difference ◽

Disease Free

AbstractAdjuvant chemotherapy decreases the risk of breast cancer recurrence in patients with breast cancer. In addition, it increases the rate of survival. Therefore, various chemotherapy regimens are administered in the treatment of breast cancer. The efficacy of taxane-based adjuvant chemotherapies has been demonstrated in various trials. This trial was designed to retrospectively evaluate the efficacy of taxane-based chemotherapies in lymph node-positive, early-stage Turkish breast cancer patients. 29 patients receiving TAC regimen and 29 patients receiving AC+P regimen were evaluated. 6 courses of TAC regimen were administered every 3 weeks (docetaxel 75 mg/m2, doxorubicine 50 mg/m2, cyclophosphamide 500 mg/m2). The other patient group was administered AC+P regimen (4 courses of doxorubicin 60mg/m2, cyclophosphamide 600 mg/m2 combination every 2 weeks, followed by paclitaxel 175 mg/m2 for 4 courses every 2 weeks). The 1-year, 2-year and 3-year disease-free survival (DFS) rates were 96.3%, 81.1% and 72.8% respectively. No significant difference was detected in DFS between premenopausal and postmenopausal patients on the taxane regimen (p=0.82). There was no significant difference in DFS between estrogen or progesterone receptor positive and negative patients (p=0.46). Disease-free survival of patients receiving TAC and AC+P adjuvant chemotherapy regimen was compared. The follow-up period of patients on AC+P chemotherapy was longer than those receiving TAC (AC+P mean 38.6±12.8 months, TAC mean 17.1±5.4 months). No significant difference was observed upon evaluation of both treatment arms with respect to DFS (p=0.92). In conclusion, this trial once more demonstrated that taxane-based adjuvant chemotherapy was effective and safe in lymph node-positive, early-stage Turkish breast cancer patients.

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Comparison of the effectiveness and complications of half and full doses of pegfilgrastim in breast cancer patients

Journal of Clinical Oncology ◽

10.1200/jco.2007.25.18_suppl.11058 ◽

2007 ◽

Vol 25 (18_suppl) ◽

pp. 11058-11058

Author(s):

E. E. Lower ◽

M. E. Bartelt ◽

S. Harman

Keyword(s):

Breast Cancer ◽

Bone Pain ◽

Early Stage ◽

Fisher Exact Test ◽

Breast Cancer Patients ◽

Myelosuppressive Chemotherapy ◽

Exact Test ◽

Significant Difference ◽

Reduced Toxicity ◽

Dose Dense

11058 Background: Pegfilgrastim (G-CSF) is a longer half-life synthetic growth factor used to reduce the incidence of infection following myelosuppressive chemotherapy but is associated with bone pain and hypergranulocytosis. Little data exists regarding efficacy and possible reduced toxicity with lower doses. Methods: A retrospective review identified early stage breast cancer pts who received reduced doses of G-CSF. Data collected prior to and after each dose of G-CSF included total white blood cell count (WBC), absolute granulocyte count (AGC),patient age, type and dose of chemotherapy, and stage of breast cancer. The occurrence of fever and infection was compared between the full and reduced dose groups. Pts completed a Likert scale (1–5) rating bone pain after each dose of G-CSF. Results: Thirty four pts received adjuvant treatment including adriamycin-cyclophosphamide (AC) followed by taxane (T) in 12, dose dense AC-T in 13, other regimens in 9. The median age was 53 years (range of 36 to 82). Thirty-two pts initially received 6 mcg but were reduced to 3mcg due to drug toxicity. Two pts received only 3mcg doses. There was a significant difference in the WBC post chemotherapy for the 98 treatments with 6 mcg (8400 (3000–49,600) cells/cu mm (Median (Range)) versus 116 treatments with 3 mcg (7600 (3000–18,900) cells/cu mm (p<0.02). There was no significant difference between the post chemotherapy AGC for the 6 mcg (6000 (2200–38,000) cells/cu mm versus the 3 mcg (5800 (1000–16,600) cells/cu mm. Six pts receiving 6 mcg had a post G-CSF WBC > 20,000 cells/cu mm vs none receiving 3 mcg (Fisher exact test, p<0.01). No WBC < 2,000 cells/cu mm or neutropenia of <1000 cells/cu mm was noted with either regimen. Reported fever and infection was not significantly different between the 6 and 3 mcg doses (Fever: 6 mcg 3/98 (3.1%) vs 3 mcg 5/116 (4.3%); Infections: 6 mcg 5/98 (5.1%) vs 3 mcg 7/116 (6.0%)). Bone pain was more severe after 6 mcg dose than the 3 mcg dose (P < 0.02). Conclusions: Although 6 mcg G-CSF was associated with a significantly higher total WBC, pts receiving 3 mcg G-CSF did not experience a difference in incidence of fever, infections, or neutropenia. However, lower doses were associated with significantly less bone pain and hypergranulocytosis. No significant financial relationships to disclose.

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Paclitaxel-induced peripheral neuropathy in early-stage breast cancer patients.

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.15_suppl.e12503 ◽

2020 ◽

Vol 38 (15_suppl) ◽

pp. e12503-e12503

Author(s):

Jacqueline Liu ◽

Hormozan Sorooshian

Keyword(s):

Breast Cancer ◽

Peripheral Neuropathy ◽

Growth Factor ◽

Side Effect ◽

Early Stage ◽

Early Stage Breast Cancer ◽

Breast Cancer Patients ◽

Nccn Guidelines ◽

Significant Difference ◽

Dose Dense

e12503 Background: Peripheral neuropathy is a major dose-limiting side effect of paclitaxel and can persist for up to two years after completing treatment, greatly affecting both the course of chemotherapy and quality of patients. Few studies have characterized the side effect profiles of two commonly used paclitaxel-based adjuvant regimens, dose-dense biweekly paclitaxel with growth factor support (ddP, 175 mg/m2 biweekly for four cycles) and weekly paclitaxel (wP, 80 mg/m2 weekly for 12 cycles). Conflicting results exist regarding the incidence of paclitaxel-induced neuropathy related to either administration scheme. Methods: This is a data-only retrospective cohort study that consisted of adult patients with early-stage breast cancer who received either ddP or wP at Kaiser Permanente Diablo Service Area (Walnut Creek and Antioch Medical Centers) between January 1, 2010 and January 1, 2019. The primary endpoint was the proportion of patients with dose-limiting chemotherapy-induced peripheral neuropathy (DL CIPN). Results: 244 patients were included in the final analysis with 159 and 85 patients receiving wP and ddP, respectively. Baseline demographics were well matched between the two groups. There was no significant difference in the proportion of patients who experienced DL CIPN with wP (17.6%) compared to ddP (19.1%) (p = 0.647). Grade 3 or 4 adverse events occurred in 8.9% of patients who received wP and 10.6% of patients who received ddP. No significant difference was observed (p = 0.650). Conclusions: The results of this study support the current National Comprehensive Cancer Network (NCCN) guidelines, which recommend dose-dense doxorubicin and cyclophosphamide (ddAC) followed by either sequential wP or sequential ddP with growth factor support as preoperative and/or adjuvant therapy for the treatment of early-stage breast cancer. The selection of an appropriate paclitaxel schedule is provider preference and largely based on the consideration of patient tolerability. These findings suggest that the concern for paclitaxel-induced peripheral neuropathy, including DL CIPN, may potentially play a smaller role in helping guide clinicians who are choosing between the two paclitaxel-based adjuvant regimens.

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Impact of oncotype Dx score on treatment and long-term outcomes.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.e12518 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. e12518-e12518

Author(s):

Surbhi Warrior ◽

Joshua Thomas ◽

Elizabeth Behrens ◽

Ruta D. Rao

Keyword(s):

Breast Cancer ◽

Hormone Therapy ◽

Early Stage ◽

Prospective Trial ◽

Minority Women ◽

Oncotype Dx ◽

Breast Cancer Patients ◽

Long Term Outcomes ◽

Significant Difference

e12518 Background: Oncotype dx is a 21 gene breast cancer assay that helps predict benefit of chemotherapy in early-stage hormone receptor positive (HR+), HER2 negative, 0 to 3 node positive breast cancer as reported by TAILORx and RxPonder trials. Both trials found no benefit of adjuvant therapy in mid-range scores of 11-25 with the exception of some benefit in age under 50 or premenopausal status, no benefit if score was 0-10, and benefit of chemotherapy if >25. Methods: All breast cancer patients between 2019-2020 were chart checked to evaluate oncotype dx scores. Patient characteristics were analyzed between oncotype dx scores of 0-10, 11-25, and >25 using X square tests. 2000-2020 institutional cancer registry data was analyzed to understand recurrence and mortality in patients with oncotype dx testing. Results: 173 patients had oncotype dx testing between 2019-2020, and most were HR+, HER2-, and had 0-3 lymph nodes. There was no difference in race or ethnicity between the groups of oncotype dx scores (Table), and average age at diagnosis for all three groups was 58 years. More patients with lower oncotype dx score had hormone therapy, but this was not significant (0-10 at 93.6%, 11-25 at 90.8%, and >25 at 82.1%, p=0.26). Patients with a higher oncotype score were significantly more likely to have chemotherapy (0-10 at 0%, 11-25 at 17.3%, and >25 at 82.1%, p<0.01). When looking at long term outcomes, the mortality rate was highest in the 11-25 score group at 9.5%, but was not significantly higher than 0-10 at 4.7% and >25 at 2.1% (p=0.15). The recurrence was highest in the 0-10 group at 5.4%, but not significant compared to the 11-25 group at 4.1% and >25 group at 4.2% (p=0.09). Conclusions: Race, ethnicity, and age does not impact predisposition to high oncotype dx score, which is interesting since literature shows minority women have higher mortality rates. This could be because oncotype dx looks at early-stage breast cancers and many minority women have later stages at diagnosis. There was no difference in which group received hormone therapy and there was significantly higher rate of chemotherapy administration in patients with scores >25, which is consistent with prospective trial recommendations. When evaluating long term outcomes between oncotype dx groups over 20 years, there was no significant difference in recurrence of disease or mortality indicating that oncotype dx scoring accurately predicted overall benefit of chemotherapy.[Table: see text]

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Biópsia do Gânglio Sentinela Guiada por Fluorescência no Cancro da Mama: Taxa de Deteção e Performance Diagnóstica

Acta Médica Portuguesa ◽

10.20344/amp.10395 ◽

2018 ◽

Vol 31 (12) ◽

pp. 706

Author(s):

Teresa Vaz ◽

Susy Costa ◽

Bárbara Peleteiro

Keyword(s):

Breast Cancer ◽

Lymph Node ◽

Sentinel Lymph Node ◽

Indocyanine Green ◽

Detection Rate ◽

Early Stage ◽

Lymph Node Staging ◽

Breast Cancer Patients ◽

Detection Rates ◽

Significant Difference

Introduction: Sentinel lymph node biopsy is currently the standard surgical procedure for lymph node staging in patients with early stage breast cancer. It is performed using different techniques, such as the injection of vital dyes and / or radioisotopes and, more recently, guided by fluorescence using Indocyanine green. The aim of this study is to assess the detection rate of sentinel lymph node using Indocyanine green in breast cancer patients according to factors related to the patient and the tumor.Material and Methods: Retrospective study of a random sample of patients with breast cancer, treated and followed at Centro Hospitalar São João, in Porto, between 2012 and 2016.Results: Indocyanine green detection rate was over 90% and its diagnostic accuracy was similar to other methods described in the presence of metastatic involvement of lymph nodes.Discussion: There was no statistically significant difference between the three methods in the detection rates in subgroups of older women, with normal weight and in those who underwent previous surgery in breast or axilla or neo-adjuvant chemotherapy.Conclusion: Indocyanine green is a potential alternative method to other sentinel lymph node screening techniques, appearing as a future option for breast cancer centers with no nuclear medicine department. However, it is essential to carry out further research in order to define the ideal patients’ profile that maximizes the method’s effectiveness.

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