Hazard of Recurrence among Women after Primary Breast Cancer Treatment—A 10-Year Follow-up Using Data from SEER-Medicare

Liu, Cheng; Swartz, Michael D.; Zhao, Hui; Kapadia, Asha S.; Lai, Dejian; Rowan, Paul; Buchholz, Thomas A.; Giordano, Sharon H.

doi:10.1158/1055-9965.epi-11-1089

Cited by 111 publications

(83 citation statements)

References 29 publications

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“…1,116 It has been well documented that, in the first 5 years after treatment, breast cancer patients face the highest risk of local recurrence. The peak hazard of local recurrence is between 2 and 3 years after surgery, as seen in many studies, including the Oxford overview 4,117,118 ( Figure 33). …”

Section: Accrual Power and Follow-up Durationmentioning

confidence: 81%

An international randomised controlled trial to compare TARGeted Intraoperative radioTherapy (TARGIT) with conventional postoperative radiotherapy after breast-conserving surgery for women with early-stage breast cancer (the TARGIT-A trial)

Vaidya

Wenz

Bulsara

et al. 2016

Health Technol Assess

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BackgroundBased on our laboratory work and clinical trials we hypothesised that radiotherapy after lumpectomy for breast cancer could be restricted to the tumour bed. In collaboration with the industry we developed a new radiotherapy device and a new surgical operation for delivering single-dose radiation to the tumour bed – the tissues at highest risk of local recurrence. We named it TARGeted Intraoperative radioTherapy (TARGIT). From 1998 we confirmed its feasibility and safety in pilot studies.ObjectiveTo compare TARGIT within a risk-adapted approach with whole-breast external beam radiotherapy (EBRT) over several weeks.DesignThe TARGeted Intraoperative radioTherapy Alone (TARGIT-A) trial was a pragmatic, prospective, international, multicentre, non-inferiority, non-blinded, randomised (1 : 1 ratio) clinical trial. Originally, randomisation occurredbeforeinitial lumpectomy (prepathology) and, if allocated TARGIT, the patient received it during the lumpectomy. Subsequently, the postpathology stratum was added in which randomisation occurredafterinitial lumpectomy, allowing potentially easier logistics and a more stringent case selection, but which needed a reoperation to reopen the wound to give TARGIT as a delayed procedure. The risk-adapted approach meant that, in the experimental arm, if pre-specified unsuspected adverse factors were found postoperatively after receiving TARGIT, EBRT was recommended. Pragmatically, this reflected how TARGIT would be practised in the real world.SettingThirty-three centres in 11 countries.ParticipantsWomen who were aged ≥ 45 years with unifocal invasive ductal carcinoma preferably ≤ 3.5 cm in size.InterventionsTARGIT within a risk-adapted approach and whole-breast EBRT.Main outcome measuresThe primary outcome measure was absolute difference in local recurrence, with a non-inferiority margin of 2.5%. Secondary outcome measures included toxicity and breast cancer-specific and non-breast-cancer mortality.ResultsIn total, 3451 patients were recruited between March 2000 and June 2012. The following values are 5-year Kaplan–Meier rates for TARGIT compared with EBRT. There was no statistically significant difference in local recurrence between TARGIT and EBRT. TARGIT was non-inferior to EBRT overall [TARGIT 3.3%, 95% confidence interval (CI) 2.1% to 5.1% vs. EBRT 1.3%, 95% CI 0.7% to 2.5%;p = 0.04; Pnon-inferiority = 0.00000012] and in the prepathology stratum (n = 2298) when TARGIT was given concurrently with lumpectomy (TARGIT 2.1%, 95% CI 1.1% to 4.2% vs. EBRT 1.1%, 95% CI 0.5% to 2.5%;p = 0.31; Pnon-inferiority = 0.0000000013). With delayed TARGIT postpathology (n = 1153), the between-group difference was larger than 2.5% and non-inferiority was not established for this stratum (TARGIT 5.4%, 95% CI 3.0% to 9.7% vs. EBRT 1.7%, 95% CI 0.6% to 4.9%;p = 0.069; Pnon-inferiority = 0.06640]. The local recurrence-free survival was 93.9% (95% CI 90.9% to 95.9%) when TARGIT was given with lumpectomy compared with 92.5% (95% CI 89.7% to 94.6%) for EBRT (p = 0.35). In a planned subgroup analysis, progesterone receptor (PgR) status was found to be the only predictor of outcome: hormone-responsive patients (PgR positive) had similar 5-year local recurrence with TARGIT during lumpectomy (1.4%, 95% CI 0.5% to 3.9%) as with EBRT (1.2%, 95% CI 0.5% to 2.9%;p = 0.77). Grade 3 or 4 radiotherapy toxicity was significantly reduced with TARGIT. Overall, breast cancer mortality was much the same between groups (TARGIT 2.6%, 95% CI 1.5% to 4.3% vs. EBRT 1.9%, 95% CI 1.1% to 3.2%;p = 0.56) but there were significantly fewer non-breast-cancer deaths with TARGIT (1.4%, 95% CI 0.8% to 2.5% vs. 3.5%, 95% CI 2.3% to 5.2%;p = 0.0086), attributable to fewer deaths from cardiovascular causes and other cancers, leading to a trend in reduced overall mortality in the TARGIT arm (3.9%, 95% CI 2.7% to 5.8% vs. 5.3%, 95% CI 3.9% to 7.3%;p = 0.099]. Health economic analyses suggest that TARGIT was statistically significantly less costly than EBRT, produced similar quality-adjusted life-years, had a positive incremental net monetary benefit that was borderline statistically significantly different from zero and had a probability of > 90% of being cost-effective. There appears to be little uncertainty in the point estimates, based on deterministic and probabilistic sensitivity analyses. If TARGIT were given instead of EBRT in suitable patients, it might potentially reduce costs to the health-care providers in the UK by £8–9.1 million each year. This does not include environmental, patient and societal costs.LimitationsThe number of local recurrences is small but the number of events for local recurrence-free survival is not as small (TARGIT 57 vs. EBRT 59); occurrence of so few events (< 3.5%) also implies that both treatments are effective and any difference is unlikely to be large. Not all 3451 patients were followed up for 5 years; however, more than the number of patients required to answer the main trial question (n = 585) were followed up for > 5 years.ConclusionsFor patients with breast cancer (women who are aged ≥ 45 years with hormone-sensitive invasive ductal carcinoma that is up to 3.5 cm in size), TARGIT concurrent with lumpectomy within a risk-adapted approach is as effective as, safer than and less expensive than postoperative EBRT.Future workThe analyses will be repeated with longer follow-up. Although this may not change the primary result, the larger number of events may confirm the effect on overall mortality and allow more detailed subgroup analyses. The TARGeted Intraoperative radioTherapy Boost (TARGIT-B) trial is testing whether or not a tumour bed boost given intraoperatively (TARGIT) boost is superior to a tumour bed boost given as part of postoperative EBRT.Trial registrationCurrent Controlled Trials ISRCTN34086741 and ClinicalTrials.gov NCT00983684.FundingUniversity College London Hospitals (UCLH)/University College London (UCL) Comprehensive Biomedical Research Centre, UCLH Charities, Ninewells Cancer Campaign, National Health and Medical Research Council and German Federal Ministry of Education and Research (BMBF). From September 2009 this project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 20, No. 73. See the NIHR Journals Library website for further project information.

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Section: Accrual Power and Follow-up Durationmentioning

confidence: 81%

An international randomised controlled trial to compare TARGeted Intraoperative radioTherapy (TARGIT) with conventional postoperative radiotherapy after breast-conserving surgery for women with early-stage breast cancer (the TARGIT-A trial)

Vaidya

Wenz

Bulsara

et al. 2016

Health Technol Assess

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“…Another potential issue is that we included patients without recurrence for 36 months, and defined recurrence as receipt of a new chemotherapy regimen. Despite the fact that we used methods similar to those used in other studies to define recurrence, [40][41][42][43] we acknowledge that this approach may not capture patients who chose not to receive chemotherapy, as suggested by a recent paper. 44 We do not feel this would have had a large impact on our sample population, as we required that patients survive 3 years, which would have been less likely without chemotherapy.…”

Section: Discussionmentioning

confidence: 99%

Adherence to colonoscopy at 1 year following resection of localized colon cancer: a retrospective cohort study

Neugut

Zhong

Lebwohl

et al. 2018

Therap Adv Gastroenterol

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Background: For patients with stages I-III colon cancer who have undergone surgical resection, guidelines recommend surveillance colonoscopy at 1 year. However, limited data exist on adherence and associated factors. We aimed to determine the rate of adherence to surveillance colonoscopy at 1 year among nonmetastatic colon cancer patients who underwent resection and factors associated with adherence. Methods: In this population-based retrospective cohort study, the Surveillance, Epidemiology, and End Results (SEER)-Medicare database was used. We identified patients with stages I-III colon cancer who underwent surgical resection and survived >3 years without recurrence (no chemotherapy after 8 months) from 2002-2011. Our primary outcome was a colonoscopy claim 10-15 months after resection. We used multivariable regression analysis to assess associations between sociodemographic and clinical factors and receipt of timely colonoscopy. Results: Among 28,732 patients who survived >3 years without recurrence, 7967 (28%) did not undergo colonoscopy; 12,033 (42%) had it at one year, with 3159 (11%) before 10 months and 5573 (19%) after 15 months. Decreased adherence was associated with older age; being male versus female; being black or Hispanic versus white; higher tumor stage; left-sided tumors versus right sided; and increased comorbidities. Chemotherapy receipt was associated with increased adherence (odds ratio 2.06; 95% confidence interval 1.88-2.24). Conclusions:In a large population-based sample of individuals aged ⩾ 65 years, only 42% of colon cancer survivors underwent 1-year surveillance colonoscopy. Demographic and clinical factors were associated with adherence.

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“…Tumor size in the setting of regional disease is an independent prognostic factor with five-year overall survival (OS) for tumors ≤ 2 cm, 2.1 to 5 cm and ≥ 5 cm being 95, 82 and 63 percent, respectively [10] . Nodal status also plays a role with any nodal involvement lowering the survival rate at five years [11] .…”

Section: Patient Selection/indications For Treatmentmentioning

confidence: 99%

Adjuvant chemotherapy in breast cancer: To use or not to use, the anthracyclines

Crozier

Swaika

Moreno-Aspitia

2014

WJCO

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Breast cancer continues to be one of the leading causes of cancer mortality in the world. The treatment generally involves multiple modalities including surgery, radiation and/or chemotherapy. Anthracyclines, one of the first chemotherapeutic agents introduced in the 1960s, has been the backbone for the last 30 years and has been used extensively so far. However, the cardiac toxicity and the concern for secondary hematological malignancy has always been a challenge. A better understanding of the tumor biology, role of Her2 expression and the discovery of trastuzumab and other anti-Her 2 agents along with other effective novel therapeutic options, have revolutionized the treatment for breast cancer. The role of anthracyclines has come under close scrutiny, especially in the adjuvant setting for patients with early stage breast cancer and those with low or intermediate risk of disease recurrence. Recent studies have highlighted such a shift in the use of anthracyclines in both the academic and community clinical practice. However, in patients with a high risk of relapse, anthracyclines still hold promise. Ongoing clinical trials are underway to further define the role of anthracyclines in such a patient population. This review highlights the development, clinical utility, limitations and potential future use of anthracyclines in the adjuvant setting for patients with breast cancer. We consulted PubMed, Scopus, MEDLINE, ASCO annual symposium abstracts, and http://clinicaltrials.gov/ for the purpose of this review. Crozier JA, Swaika A, Moreno-Aspitia A. Adjuvant chemotherapy in breast cancer: To use or not to use, the anthracyclines.

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Hazard of Recurrence among Women after Primary Breast Cancer Treatment—A 10-Year Follow-up Using Data from SEER-Medicare

Cited by 111 publications

References 29 publications

An international randomised controlled trial to compare TARGeted Intraoperative radioTherapy (TARGIT) with conventional postoperative radiotherapy after breast-conserving surgery for women with early-stage breast cancer (the TARGIT-A trial)

An international randomised controlled trial to compare TARGeted Intraoperative radioTherapy (TARGIT) with conventional postoperative radiotherapy after breast-conserving surgery for women with early-stage breast cancer (the TARGIT-A trial)

Adherence to colonoscopy at 1 year following resection of localized colon cancer: a retrospective cohort study

Adjuvant chemotherapy in breast cancer: To use or not to use, the anthracyclines

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