Primary Surgery with Systemic Therapy in Patients with de Novo Stage IV Breast Cancer: 10-year Follow-up; Protocol MF07-01 Randomized Clinical Trial

Soran, Atilla; Özmen, Vahit; Özbaş, Serdar; Karanlık, Hasan; Müslümanoğlu, Mahmut; İğci, Abdullah; Cantürk, Nuh Zafer; Utkan, Zafer; Evrensel, Türkkan; Sezgın, Efe; Özaslan, Cihangir; Uras, Cihan; Aksaz, Erol; Soyder, Aykut; Çöl, Cavit; Cabıoğlu, Neslihan; Güllüoğlu, Bahadır M.; Erdem, Ergün

doi:10.1016/j.jamcollsurg.2021.08.686

Cited by 65 publications

(68 citation statements)

References 36 publications

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“…As with the question regarding the oligometastatic subset, existing data do not specifically address the contribution of primary site local therapy toward achieving long survival. We note that the long-term follow-up results of MF07-01 do suggest a population of long-term survivors 8 ; detailed information on these would be of some interest. It is possible that they consist of patients who entered with minimal metastatic disease, and included some who were assumed to have metastatic disease on the basis of a solitary, unbiopsied bone lesion.…”

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confidence: 88%

Reply to B. Ulaş Kahya et al and A. Soran et al

Khan

Zhao

Goldstein

et al. 2022

JCO

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Thank you for the opportunity to respond to correspondences from Ulas ¸Kahya et al 1 and Soran et al 2 regarding our manuscript. 3 We thank both groups for their interesting and detailed questions regarding our recent report on the results of E2108, a phase III trial testing the value of local regional therapy to the primary site in women with newly diagnosed metastatic breast cancer that was resectable following optimal systemic therapy. 3

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confidence: 88%

Reply to B. Ulaş Kahya et al and A. Soran et al

Khan

Zhao

Goldstein

et al. 2022

JCO

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“…To date, results of four randomized phase 3 trials have been reported [25][26][27][28]. Only in one of these trials, early local therapy of the primary breast tumor improved overall survival in patients with de novo metastatic disease after 10 years of follow-up in a very selected group of patients (i.e., those with HR+/HER2− BC of less than 55 years of age and solitary bone-only metastasis) [28]. Despite better local control, surgery did not improve quality of life [25,27,29].…”

Section: Specific Sites Of Metastasesmentioning

confidence: 99%

“…In a prospective registry study (BOMET MF 14-01), 505 patients with de novo, bone-only MBC demonstrated an improvement in 3-year OS in association with locoregional therapy of the primary tumor (in combination with systemic therapy) compared to systemic therapy alone [30]. Consequently, primary tumor removal in stage IV BC is not recommended with the expectation of survival improvement even in patients with bone-only disease (LoE 1b/B/AGO+/−) [25][26][27][28][29][30]. Only patients with limited or oligometastatic disease and a good response to systemic treatment should be considered for surgical procedures and/or stereotactic treatment of the metastatic sites (LoE 2b/C/AGO+).…”

Section: Specific Sites Of Metastasesmentioning

confidence: 99%

AGO Recommendations for the Diagnosis and Treatment of Patients with Locally Advanced and Metastatic Breast Cancer: Update 2022

et al. 2022

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“…Conversely, a number of retrospective (8) studies have suggested that surgical resection is correlated with a survival benefit in pMBC patients (9,10). However, selection bias (11) and other potential confounding factors (12) may have affected these results.…”

Section: Introductionmentioning

confidence: 99%

The prognostic role of surgery and a nomogram to predict the survival of stage IV breast cancer patients

Liu¹,

Wang²,

Feng³

et al. 2022

Gland Surg

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Background: Since numerous retrospective studies and prospective trials have shown divergent results, whether the surgical excision of the primary tumor results in survival benefits for de-novo stage IV breast cancer patients is inconclusive. Consequently, we need a prediction model of prognosis, judge the efficiency of breast surgery, and identify the advanced breast cancer patients who would benefit from surgery.Methods: We analyzed the data of 2,747 metastatic breast cancer patients (the surgery group) and 4,508 patients (the non-surgery group) from the Surveillance, Epidemiology, and End Results (SEER) database during 2010-2015. Propensity score matching (PSM) was used to attain a balance between the covariates of both groups. We then assessed the potential risk factors for the breast cancer-specific survival (BCSS) of patients in the non-surgery group by Cox regression and constructed a nomogram to predict BCSS. All the patients were classified into different risk groups based on the median risk score obtained from the nomogram. The hazard ratios of BCSS and overall survival (OS) of patients in the two groups were calculated.Results: After PSM, 2,288 patients severally in the two groups (the surgery group and the non-surgery group) were enrolled in the study. A nomogram incorporating 13 potential risk factors (i.e., age, race, cohabitation status, income, tumor grade, histotype, tumor size, lymph node status, molecular subtype, metastasis to brain, liver, lung, and chemotherapy) was constructed using the data of patients in the nonsurgery group. The C statistics for the internal (patients in the non-surgery group) and external (patients in the surgery group) validation of the nomogram were 0.70 [95% confidence interval (CI), 0.69-0.71] and 0.73 (95% CI, 0.72-0.74), respectively. In the low-risk group, patients in the surgery group had lower risks of breast cancer-specific mortality (BCSM) (hazard ratio =0.53; 95% CI, 0.47-0.59; P for interaction =0.014) and overall mortality (OM) (hazard ratio =0.52; 95% CI, 0.46-0.58; P for interaction =0.002) than those in the non-surgery group. Conclusions: Breast surgery might improve the survival of metastatic breast cancer patients in the lowrisk group. The established nomogram could provide a reference for clinicians in enabling personalized treatment among advanced breast cancer patients.

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Primary Surgery with Systemic Therapy in Patients with de Novo Stage IV Breast Cancer: 10-year Follow-up; Protocol MF07-01 Randomized Clinical Trial

Cited by 65 publications

References 36 publications

Reply to B. Ulaş Kahya et al and A. Soran et al

Reply to B. Ulaş Kahya et al and A. Soran et al

AGO Recommendations for the Diagnosis and Treatment of Patients with Locally Advanced and Metastatic Breast Cancer: Update 2022

The prognostic role of surgery and a nomogram to predict the survival of stage IV breast cancer patients

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