Background

Intraoperative imprint and exfoliative cytology (IEC) or frozen section (FS) are margin assessment techniques to reduce reoperation risk. These techniques reduce the rate of positive margin on permanent section (PS) after breast conservation surgery (BCS), which lead to reduction of reoperation. The rate of positive margin using these techniques are reported accounts for 6–19% of BCS. However, previous studies reported only the single use of each method. The purpose of this study was to elucidate the efficacy of using IEC followed by FS as intraoperative margin assessment (IMA) in BCS regarding the positive margin rate of PS.

Methods

Four hundred and fifty-one women who were admitted to our institution and underwent BCS between January 2013 and November 2018, and participated in this study. At first, IEC was performed as IMA. When the margin was likely to be positive by IEC result, FS was added. Additional excision was performed in patients with positive margin FS. We have analyzed the rate of positive margin on PS based on our margin assessment techniques.

Results

Of 451 patients, 121 (26.8%) patients were IEC-positive and 330 (73.2%) patients were IEC-negative. Among these 121 patients who were added FS, 87 (71.9%) patients were FS-positive. Also, 10 (3.0%) of 330 patients with IEC-negative had positive margin with PS. Of 34 patients with FS-negative, no PS-positive patients were found. Though 87 patients with FS-positive received additional excision, only 3 patients resulted in PS-positive. Overall positive margin rate on final pathology according to PS was 2.9% (13 of 451 patients).

Conclusions

Technique of IMA using IEC followed by FS improved positive margin rate of PS compared to that in the previous studies. Our techniques should contribute to reducing reoperation risk.

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.

Background

Neoadjuvant chemotherapy plus anti-HER2 treatment is increasingly becoming the treatment of choice for all but the lowest risk HER2+ early and locally advanced breast cancer (BC). Patients achieving a pathological complete response (pCR) have substantially better outcomes compared with non-pCR. We evaluated the pCR rates following neoadjuvant systemic therapy in our HER2+ BC population and determined the influence of tumour and patient characteristics, and adverse events on pCR rates, disease free survival (DFS) and overall survival (OS).

Methods

We retrospectively identified patients with early and locally advanced HER2+ BC who received neoadjuvant treatment from January 2013 to December 2017 and underwent subsequent surgery. pCR was defined as ypT0/is N0. Demographics, patient and disease characteristics, pathological responses, toxicities, dose delays and reductions were recorded. Statistical analysis was undertaken using Chi-squared, Kaplan Meier and Log-rank tests.

Results

300 patients were identified. Median age was 51 years (range 25-78) and 286 (95.3%) patients had performance status (PS) 0. 11 (4.0%) patients had clinical stage I, 189 (63.0%) stage II and 100 (33.0%) stage III disease. 204 (68.0%) had grade 3 disease and 282 (94.0%) ductal histology. 185 (61.7%) patients had ER+ disease and 115 (38.3%) ER- disease. 155 (52.0%) patients were treated with chemotherapy plus Trastuzumab. 143 (48.0%) patients had chemotherapy plus Trastuzumab and Pertuzumab. pCR rate in the overall population was 54.3% and significantly better in the ER- compared with the ER+ subgroup ( 68.7 vs 45.4 %; p < 0.001). Patients on dual anti-HER2 blockade achieved higher pCR rates compared with those on Trastuzumab (56.6 vs 52.2%) although the difference was not statistically significant (p = 0.448). pCR rates were not influenced by age, PS, dose reductions or dose delays but were significantly lower in case of chemotherapy early discontinuation. With a median follow-up of 23 months, median DFS and OS were not reached.

Conclusions

In our analysis, pCR rate was similar to published data in the literature and was higher in the ER-/HER2 positive subgroup.

Legal entity responsible for the study

The Breast Unit, The Royal Marsden Hospital.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.

Background

Accelerated hypofractionated or conventional RT post BCS reoprted similar recurrence rates and cosmetic outcomes. Conventional RT delivers radiation dose of 50 Gy in 25 fractions in 5 weeks. Radiobiologic models suggests higher radiation doses over shorter period of time may produce similar outcomes. An accelerated, hypofractionated treatment also might be more convenient for patients and conserve resources, in developing countries where patient load is too much and the resources are limited.

Methods

100 patients were randomized to receive hypofractionated radiation with 40 Gy/15#/3 weeks and the control group receiving 50 Gy/25 #/5 weeks. Post radiation therapy all the patients were followed up regularly on monthly interval. Follow up assessment for quality of life made by EORTC questionnaire. All the patients in both study and control groups were assessed regularly and records maintained at weekly intervals with special attention to toxicity, physical examination, QOL scores and subjective evaluation were documented.

Results

The patients in the study group as well as the control group were well matched in terms of age distribution (p value - 0.235).The difference in between both the arms regarding severity and incidence of dermatological toxicities was statistically insignificant (p value - 0.260) at the end of treatment. Radiation induced esophagitis was the main GI toxicity which increased towards the end of the treatment but statistically it was not significant in both the groups (p value - 0.356). Equal number of patients from study and control group showed grade I pulmonary toxicity after the follow up period of 6 months. The difference in both the group was statistically insignificant (p value -1.0).

Conclusions

The hypofractionated radiotherapy in post operative breast cancer patients is more relevant in the present context in our country where the case load is more and availability of the equipment is a major issue. So treating patients with hypofractionated RT will reduce the burden on the machine and will also reduce the number of the visits of the patient to the hospital. This short course RT has improved the compliance very much.

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.

Background

The American Joint Committee on Cancer (AJCC) 8^th edition staging system introduced prognostic stage groups based on anatomic stage combined with biologic factors. We aimed to validate the AJCC prognostic classification in a large cohort of patients with HER2-positive breast cancer enrolled in the prospective ShortHER trial.

Methods

The ShortHER trial randomized 1253 HER2-positive patients to receive 9 weeks or 1 year of trastuzumab in combination with anthracycline and taxane chemotherapy. Patients were classified according to the classic AJCC anatomic groups and the AJCC prognostic groups (8^th edition). Distant disease-free survival (DDFS) was calculated as the time from randomization to relapse at a distant site or death. The Harrell’s C-index was used to compare the prognostic performance of the two staging systems.

Results

1244 patients had complete clinicopathological data for both AJCC anatomic and AJCC prognostic stage classifications. Compared with the anatomic AJCC, the prognostic AJCC moved 41.6% (n = 517) of the patients to a more favorable stage category: 100% of IB to IA (n = 40), 61.6% of IIA to IB or IA (n = 246), 63.0% of IIB to IB or IA (N = 94), 58.7% of IIIA to IIA or IB (n = 71) and 100% of IIIC to IIIB or IIIA (n = 66). Table shows the 5-years DDFS rates according to the two staging systems. The c-index was similar: 0.69209 for anatomic stage and 0.69249 for prognostic stage (P = 0.975).

Table: 88O

Conclusions

The AJCC prognostic classification reallocated 41.6% of HER2-positive patients to a more favorable stage category, while maintaining a similar prognostic performance as compared to the classic anatomic stage. With the AJCC prognostic staging, 59% of patients were classified as IA and showed an excellent prognosis after adjuvant treatment.

Clinical trial identification

EUDRACT number: 2007-004326-25 NCI; NCT00629278.

Legal entity responsible for the study

University of Modena and Reggio Emilia; University of Padua.

Funding

Agenzia Italiana del Farmaco (AIFA, grant FARM62MC97).

Disclosure

M.V. Dieci: Fees for consultancy role and participation on advisory boards: Eli Lilly; Fees for consultancy role: Genomic Health; Fees for participation on advisory boards: Celgene. A. Frassoldati: Advisory board: Roche, Novartis; Sponsored lectures: Pfizer, Novartis, Eli Lilly. O. Garrone: Fees for participation on advisory boards: Celgene, Eisai. V. Guarneri: Institutional research grant: Roche; Advisory boards: Eli Lilly, Roche, Novartis; Speaker’s bureau: Eli Lilly, Novartis. P.F. Conte: Fees and honoraria for participation on advisory boards: Eli Lilly, Novartis, Roche, AstraZeneca. All other authors have declared no conflicts of interest.

Background

Insight in late treatment-related health problems following from breast cancer treatment is useful in anticipating on the (informational) needs of patients during follow-up. This study aimed to identify treatment-related health problems in breast cancer patients up to five years after diagnosis. Second, use of care associated to these health problems was identified.

Methods

876 surgically treated female patients diagnosed with early stage breast cancer (between 2012-2016) were asked to complete an online survey about current health problems and use of care. Multivariate logistic regression analyses were applied to determine the effect of patient and treatment characteristic on health problems.

Results

404 patients responded (46%). Median age was 62.0 years (SD: 10.9). Apart from breast surgery, patients were treated with radiotherapy (72%), chemotherapy (49%), anti-hormonal therapy (57%), and axillary dissection (21%). Ninety-three percent experienced one or more health problems. Over 50% of respondents experienced fatigue, psychological problems, and health problems regarding the breast, and/or musculoskeletal, central nervous, and reproductive system. Treatment with chemotherapy was significantly (p < 0.05) associated with an increased risk of health problems, respectively fatigue (OR:2.00), and respiratory (OR:1.81), gastrointestinal (OR:1.87), central nervous (OR:3.40), and skin problems (OR:2.62). Use of health care for one or more health problems was reported by 64% of respondents.

Conclusions

Almost all patients experienced health problems up to five years after breast cancer diagnosis, with a range of complaints existing consistently present over time. Factors associated with the development of health problems are useful to better informing patients upfront and to target follow-up care.

Legal entity responsible for the study

Netherlands Comprehensive Cancer Organisation (IKNL).

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.

Background

WSG (West German Study Group)-Protroca evaluated the efficacy and safety of primary and secondary prophylaxis (ppx) of neutropenia with lipegfilgrastim (Lonquex^®) in breast cancer (BC) patients (pts) receiving neo-adjuvant or adjuvant treatment in routine praxis.

Methods

Eligibility: histologically confirmed BC pts, age ≥18 years, prior or concurrent neo-adjuvant or adjuvant treatment with dose-dense chemotherapy (CT), or with moderate risk CT with risk factors (age >65 years, severe co-morbidities). Primary endpoint: occurrence rate of febrile neutropenia (FN) and/or severe infection (SI) (grade 3–4). Secondary endpoints: dose reductions of further CT or cycle postponement of CT after start of Lonquex^® treatment, adverse events (AEs) and serious adverse events (SAEs) related to Lonquex^® according to NCI-CTCAE Version 4.0. 47.3% (15.4%) and 38.7% (69.2%) of pts with primary (secondary) ppx received anthracycline (A)-containing dose-dense and A-containing conventionally dense regimen, respectively.

Results

Of the 255 enrolled pts (2015–2017), 248 pts were evaluable for the intent to treat (ITT) set (222 and 26 pts with primary and secondary ppx, respectively). 5 pts of the ITT set receiving Lonquex^® as primary ppx had FN grade 3–4 (2.3%). Regarding SI, 5 pts of the ITT population (2.0%) had an infection of grade 3–4; 4 pts got primary ppx (1.8%) and one received secondary ppx (3.9%). Dose reductions were only performed in 9.5% of pts (all of them receiving primary ppx). Postponement of CT cycles for >3 days was observed in 14.4% and 11.5% of pts with Lonquex^® as primary and secondary ppx, respectively. 67.6% (84.6%) and 6.3% (11.5%) of ITT pts with primary (secondary) ppx exhibited AEs and SAEs, respectively. 10.8% (92/851 AEs) and 8% (2/25 SAEs of 851 AEs) of documented AEs and SAEs, respectively, were related to Lonquex^®.

Conclusions

In WSG-Protroca, the application of Lonquex^® was effective as primary and secondary ppx in the prevention of CT-induced neutropenia. Observed adverse drug reactions and AEs were in line with the Lonquex^® summary of product characteristics and CT, respectively; no new toxicities were identified.

Legal entity responsible for the study

West German Study Group (WSG).

Funding

Teva Biotech GmbH.

Disclosure

R. Wuerstlein: Agendia, Amgen, AZ, BI, Carl Zeiss, Celgene, Daiichi-Sankyo, Esai, GE, GSK, Hexal, Lilly, MSD, Mundipharma, NanoString, Novartis, Odonate, Paxman, Palleos, Pfizer, Pierre Fabre, Puma Biotechnology, Riemser, Roche, Sandoz, Seattle Genetics, Tesaro Bio, Teva. N. Harbeck: Honoraria for consulting: Amgen, Hexal. U. Nitz: Honoraria: Genomic Health, Roche. O. Gluz: Honoraria: Genomic Health, NanoString Technologies, Roche; Travel, accommodations, expenses: Celgene; Teva. All other authors have declared no conflicts of interest.