Randomized Trial Comparing Resection of Primary Tumor with No Surgery in Stage IV Breast Cancer at Presentation: Protocol MF07-01

Soran, Atilla; Özmen, Vahit; Özbaş, Serdar; Karanlık, Hasan; Müslümanoğlu, Mahmut; İğci, Abdullah; Cantürk, Zafer; Utkan, Zafer; Özaslan, Cihangir; Evrensel, Türkkan; Uras, Cihan; Aksaz, Erol; Soyder, Aykut; Uğurlu, Ümit; Çöl, Cavit; Cabıoğlu, Neslihan; Bozkurt, Betül; Uzunköy, Ali; Köksal, Neşet; Güllüoğlu, Bahadır M.; Ünal, Bülent; Atalay, Can; Yıldırım, Erol; Erdem, Ergün; Salimoğlu, Semra; Sezer, Atakan; Koyuncu, Ayhan; Gurleyik, Gunay; Ağuş, Haluk; Ulufi, Nalan; Berberoğlu, Uğur; Dülger, Mustafa; Cengîz, Ömer; Sezgın, Efe; Johnson, R. R.

doi:10.1245/s10434-018-6494-6

Cited by 268 publications

(337 citation statements)

References 42 publications

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“…10 One notable recent study of surgery for de novo stage 4 breast cancer is the MF07-01 trial sponsored by the Turkish Federation of the National Societies for Breast Disease. 11 In this study, the last statistical analysis in a median followup period of 40 months showed results that differed from those of the previous 36-month follow-up period, in which no difference in survival was noted between the surgery and no-surgery groups. The longer follow-up period showed a significant improvement in median overall survival of about 9 months.…”

contrasting

confidence: 50%

“…In the Turkish randomized study by Soran et al 11 that investigated a group of patients randomized for no surgery, the local progression and need for palliative surgery was higher and statistically significant, with 18% of patients in the no-surgery group requiring palliation surgery. This study did not clarify how many patients lost their window of opportunity for surgery because they developed unresectable chest wall or axillary lymph node disease.…”

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confidence: 98%

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Restaging Patients With Locoregional Relapse: Is There Any Benefit?

Sacchini

2019

Ann Surg Oncol

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1 poses the important and practical question of whether it is necessary to restage breast cancer patients for possible synchronous distant metastasis at the time of the first locoregional relapse, and what possible implications this may have for local and systemic patient management.The most important finding of this study was that onethird of breast cancer patients with locoregional recurrences have distant metastasis at restaging with positron emission tomography (PET) and/or computed tomography (CT) scans. Even patients at low risk for metastasis at their first diagnosis were found to have a 20-25% risk of distant metastasis at the time of locoregional relapse, supporting the postulated role of local relapses as independent prognostic factors for distant disease. 2 The authors disclosed a limitation of their study when they described it as retrospective. However, the data from the study were extracted from a prospectively maintained modern database with detailed biology and staging of cancers, making the overall analysis more robust.No clear guidelines currently exist regarding how to assess patients with locoregional recurrences. The current National Comprehensive Cancer Network (NCCN) guidelines recommend staging all patients with locoregional relapses, even if the recommendations are based on a low level of evidence consisting primarily of data from the National Cancer Database showing a 27% risk of distant metastases in patients with locoregional relapses. 3 The NCCN recommendations were stronger for patients with lymph node metastasis or chest wall relapses after mastectomy, whose risk of distant metastasis is higher.The current study had a relatively high number of locoregional relapses after conservation (35%), and the risk of distant metastasis after breast-conservation surgery was lower (23% vs. 48% after mastectomy) but still consistent with the finding that the guidelines for restaging patients with locoregional relapses should be extended to all breast cancer patients. This raises a question: When can patients benefit from a diagnosis of synchronous distant metastasis, thus justifying the restaging tests? The most obvious answer is that patients benefit when the diagnosis avoids unnecessary surgery for stage 4 breast cancer, indicating surgical and systemic treatments that are merely palliative.Surgical management for the local recurrence of breast cancer can often be complex, especially in the reconstruction phase of a pre-irradiated breast. The complication rate has been shown to increase 29.7% with implant reconstructions. 4 The high complication rate for the implant base reconstruction procedure predisposes these patients for more complex reconstruction with free or pedunculated flaps, together with the possible morbidity, high cost, and unproven benefits of this procedure. 5 In

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confidence: 50%

mentioning

confidence: 98%

Restaging Patients With Locoregional Relapse: Is There Any Benefit?

Sacchini

2019

Ann Surg Oncol

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“…[26] The incidence of synchronous distant metastasis in newly diagnosed breast cancer is up to 10%, [27] and the five-year survival rates for the diagnosed patients dramatically reduces from 99% to 26% due to distant metastasis. [26] The incidence of synchronous distant metastasis in newly diagnosed breast cancer is up to 10%, [27] and the five-year survival rates for the diagnosed patients dramatically reduces from 99% to 26% due to distant metastasis.…”

Section: Discussionmentioning

confidence: 99%

PI3Kgamma Inhibitor Attenuates Immunosuppressive Effect of Poly(l‐Glutamic Acid)‐Combretastatin A4 Conjugate in Metastatic Breast Cancer

Qin

Sheng

et al. 2019

Advanced Science

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Vascular disrupting agents (VDAs) have great potential for cancer treatment. Poly( l ‐glutamic acid)‐combretastatin A4 conjugate (PLG‐CA4) is a novel class of VDAs. Though it has notable antitumor activity, it can induce host immune responses that promote tumor growth. Here, PLG‐CA4 induces the polarization of tumor‐associated macrophages (TAMs) toward the M2‐like phenotype in 4T1 metastatic breast cancer (Control 30% vs PLG‐CA4 53%; p < 0.05). Compared to the monotherapy of PLG‐CA4, inhibition of phosphoinositide 3‐kinase gamma (PI3Kγ) attenuates the immunosuppressive effect of PLG‐CA4 treatment by decreasing the number of M2‐like TAMs (2.0 × 10 4 to 1.5 × 10 4 per tumor) and potential enhancement of cytotoxic T lymphocyte (3.0 × 10 4 to 5.7 × 10 4 per tumor). Importantly, PI3Kγ inhibitor synergizing with PLG‐CA4 significantly extends the mean survival time from 52 days in monotherapy‐treated mice to 61.8 days. Additionally, the combination of PLG‐CA4 and PI3Kγ inhibitor improves the tumor therapeutic effect of NLG919, an inhibitor of immune checkpoint indoleamine 2,3‐dioxygenase (IDO). As far as it is known, this is the first demonstrated study that VDAs induce the reshaping of macrophages to the M2‐like phenotype. The findings also indicate a potential therapeutic strategy of the combination VDAs with an accurate immune modifier in the tumor to reverse the immune resistance.

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“…This trial has been critiqued for more favorable factors in the surgery arm. 8 The Tata trial reported no improvement in overall survival between the surgery versus no surgery arm for de novo Stage IV breast cancer. The results of the Tata trial need to be interpreted with caution because not only did patients have high-risk features, many patients did not receive optimal targeted therapy.…”

Section: Dear Editormentioning

confidence: 99%