scholarly journals Difference in Estimation of Side Effects of Chemotherapy between Physicians and Patients with Early-Stage Breast Cancer: The Use of Patient Reported Outcomes (PROs) in the Evaluation of Toxicity in Everyday Clinical Practice

Cancers ◽  
2021 ◽  
Vol 13 (23) ◽  
pp. 5922
Author(s):  
Mirjana Pavlović Mavić ◽  
Robert Šeparović ◽  
Ana Tečić Vuger ◽  
Ljubica Vazdar

Knowledge about the patient’s experience and perception of side effects and their impact on daily life is crucial for the adequate planning of interventions to provide the highest attainable levels of quality of life during oncology treatment. We conducted a study on consecutive samples of 69 early breast cancer patients treated with four cycles of neoadjuvant or adjuvant anthracycline-based chemotherapy. Patients completed the questionnaire about side effects experienced after the previous cycle of chemotherapy. The questionnaire was a modified PRO for the evaluation of treatment toxicity consisting of 18 questions related to the very common and common side effects of doxorubicin and cyclophosphamide, valued from 0 to 3 according to the subjective assessment of the patient. During the same cycles of therapy, data were also collected by the physician who completed a questionnaire consisting of the same questions as the questionnaire for patients, on the same scale. Most of the side effects reported by patients were mild to moderate in intensity, while physicians reported side effects much less frequently. The results also indicated a disproportionate reporting, in which physicians reported statistically significantly fewer side effects than patients. This study reported a level of disagreement between patients and physicians in the experience of therapy toxicity. In conclusion, use of PRO in clinical practice can help us avoid physician subjectiveness in the estimation of side effects and determine the group of patients who can benefit from additional and individualized supportive care measures, which could lead to better adherence to therapy and ultimately best outcomes.

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e22126-e22126
Author(s):  
A. Barlev ◽  
M. Yong ◽  
G. Cherkowski ◽  
K. Cetin ◽  
J. Fryzek

e22126 Background: AIs and ADT are used to prevent recurrence of breast and prostate cancers but have been shown to accelerate bone loss. We estimated the prevalence of early-stage ER+ breast and prostate cancer patients on hormone therapy in the U.S., as this is not well-described in the literature. Methods: Data from the Surveillance, Epidemiology, and End Results (SEER) Program, published literature, clinical practice, and a large claims database were used. We began with the American Cancer Society's estimated number of new breast and prostate cancer cases for the year 2008. We then assessed the number of patients with localized/regional disease and ER+ tumors and those receiving primary ADT (both chemical and surgical) or AI therapy by applying proportions from SEER, published literature, clinical practice, and the claims database. Using these incident case counts, we calculated the 5-year prevalence using appropriate cohort-specific survival rates to sum the number of new and surviving cases over a 5-year period. Results: The estimated 5-year prevalence of early-stage ER+ breast cancer for women aged ≥50 years in the U.S. was 607,411, of which 293,904 (48.4%) were on AI therapy based on the claims database. However, because this data source was limited to women aged <65 years, we also used estimates from clinical practice to capture AI use for women of all ages. Based on clinical practice, 402,637 (66.3%) to 460,156 (75.8%) of early-stage ER+ breast cancer patients were on AI therapy. For early-stage prostate cancer, the estimated 5-year prevalence for all ages was 1,024,238, of which 141,451 (13.8%) were on primary ADT. However, these figures may underestimate current usage of hormone therapies, as our data and the literature show increasing trends in ADT and AI use for early-stage disease. Conclusions: Based on a combination of population-based data and the published literature, approximately half of all early-stage ER+ breast cancer patients and a modest proportion of early-stage prostate cancer patients are on hormone therapy in the U.S. [Table: see text]


2019 ◽  
Vol 5 (1) ◽  
Author(s):  
Christina Witt Bæksted ◽  
Aase Nissen ◽  
Ann S. Knoop ◽  
Helle Pappot

Abstract Background The study is based on a national cluster randomized trial investigating the effect of electronic patient-reported outcomes (ePRO) on treatment outcomes in breast cancer patients receiving adjuvant chemotherapy. All 13 oncology departments (11 clusters) treating breast cancer patients in Denmark were randomized to use electronic patient-reported outcomes with real-time clinician feedback (ePRO arm) to track symptoms or usual care for eliciting symptoms using a short paper tracking list (usual care arm). The impact of ePRO on clinical outcomes were examined, which is reported elsewhere. The purpose of the present study was to examine patient-reported experience measure (PREM) regarding communication and handling of side effects/symptoms. Methods For this sub-study, patient representatives were involved in the development of a PREM questionnaire. Patients enrolled in the cluster randomized trial completed the PREM questionnaire at their last treatment visit. Semi-structured telephone-interviews were performed with a subgroup of patients. The interviews were based on an interview guide comprised of the questions from the PREM questionnaire and aimed to elaborate on the PREM questionnaire data. Results A 12 item PREM questionnaire was developed in partnership with patient representatives. In total, 439 out of 682 patients (64.4%) included patients completed the PREM questionnaire. Telephone semi-structured interviews were performed with 22 patients. In total, 52% (ePRO arm) and 65% (usual care arm) reported having talked with the oncologist/nurse about their responses in the tracking systems before each chemotherapy cycle. Fewer patients in the ePRO arm compared to the usual care arm experienced side effects/symptoms not included in the side effect questionnaire. Patients experienced high satisfaction with oncologists’ and nurses’ handling of side effects/symptoms. Conclusions Patients experienced high satisfaction with oncologists’ and nurses’ handling of chemotherapy adverse events. The study indicates a need for a more comprehensive side effect questionnaire as tracking system covering more symptoms than the one used in usual care today. Trial registration Clinicaltrials.gov identifier NCT02996201. Registered 19 December 2016, retrospectively registered.


2021 ◽  
Author(s):  
Shi-Ping Yang ◽  
Jia Yao ◽  
Ping Zhou ◽  
Chen-Lu Lian ◽  
Jun Wang ◽  
...  

Aim: To investigate the benefit of chemotherapy among early-stage breast cancer patients with 21-gene recurrence scores of 26–30. Methods: We identified 3754 patients in the Surveillance, Epidemiology, and End Results database. Results: 57.6% of the patients received adjuvant chemotherapy. Patients with higher tumor grade, larger tumors and younger age were more likely to receive chemotherapy. The receipt of chemotherapy was independently associated with better breast cancer-specific survival than in patients without chemotherapy before (p = 0.016) and after (p = 0.043) propensity score matching. The sensitivity analyses showed that survival gain was pronounced in patients with poorly differentiated or undifferentiated disease. Conclusions: Adjuvant chemotherapy improves the outcome for early-stage breast cancer with 21-gene recurrence score of 26–30, especially for patients with high-grade tumors.


Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 3509-3509
Author(s):  
Ilene Ceil Weitz ◽  
Howard A. Liebman

Thrombotic events are well documented in patients with cancer and have frequently been described in the setting of systemic chemotherapy. We have previously reported (Thromb Haemost2002; 88:213–220) that patients treated for breast and lung cancer demonstrate significant hemostatic activation, as documented by increases in thrombin-antithrombin (TAT) complexes and D-dimers, within 1 hour of receiving chemotherapy. The hemostatic effects appear to be cumulative with baseline pretreatment levels of TAT increasing with progressive cycles of chemotherapy. In the same study, we demonstrated that a single injection of dalteparin, a LMW heparin, administered prior to therapy could suppress hemostatic activation. We proposed that the progressive increases in basal thrombin generation resulted from chemotherapy-induced increases in inflammatory cytokines. We measured plasma levels of Il-6 in the 10 women with early stage breast cancer from this study who were receiving cyclophosphamide-doxorubicin adjuvant chemotherapy. Patients had plasma samples drawn prior to each cycle of chemotherapy, and at 1 hour, 24 and 48 hours after treatment. Prior to 2nd cycle of chemotherapy the patients received 2500 U dalteparin, prior to the 4th cycle of treatment, the patients received 5000 U dalteparin. No LMW heparin was given with the 1st and 3rd cycles. There were statistically significant increases in plasma TAT and D-dimers after chemotherapy in cycles 1 and 3. There was a significant increase in basal thrombin generation as measured over the four cycles of treatment unrelated to the presence of active cancer. Both pretreatment doses of dalteparin effectively prevented increases in markers of hemostatic activation after receiving chemotherapy. With each cyle of chemotherapy the 1 hour Il-6 levels were slightly lower than the pretreatment levels, but this was not statistically significant and could reflect a direct effect of the chemotherapeutic regimen on cytokine production. However, in cycle 1 and 3 the Il-6 levels increased to greater than pretreatment levels by 48 hours. There was a statistically significant increase in plasma Il-6 levels measured prior to the 4th cycle of chemotherapy when compared to the plasma Il-6 measured prior to the 1st cycle (4.976pg/ml± 1.620 vs 3.30 pg/ml±1.005 ; P<0.05). There was a trend for the pretreatment Il-6 levels measured prior to the 3rd cycle and 21 days after receiving 2500 U dalteparin to be lower than the levels measured prior to cycle 2, although not statistically significant (4.032±2.415 vs. 6.203±3.862; p=0.072). A 21 day sample was not obtained following the fourth cycle in which 5000U dalteparin was given and therefore the effect of this dose on basal thrombin generation and Il-6 expression could not be determined. We conclude; 1) the progressively increasing basal generation of thrombin associated with systemic chemotherapy in patients with breast cancer is associated with increases in the inflammatory cytokine, Il-6. 2) The increased expression of Il-6 and possibly other cytokines may be responsible for the progressive increases in hemostatic activation with repeated cycles of chemotherapy. In our study, there is a suggestion that a LMW heparin, dalteparin, not only prevented chemotherapy-induced hemostatic activation, but may also suppress chemotherapy-related cytokine expression. However, the optimal dose of dalteparin necessary for suppression of chemotherapy-induced cytokine expression is unknown and may vary with different malignancies and chemotherapy agents.


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