Survival outcomes with 12 weeks of adjuvant or neoadjuvant trastuzumab in breast cancer

Background: There is limited access to 1 year of adjuvant trastuzumab in resource-constrained settings. Most randomized studies have failed to prove non-inferiority of shorter durations of adjuvant trastuzumab compared to 1 year However, shorter durations are often used when 1 year is not financially viable. We report the outcomes with 12 weeks of trastuzumab administered as part of curative-intent treatment. Methods: This is a retrospective analysis of patients treated at Tata Memorial Centre, Mumbai, a tertiary care cancer center in India. Patients with human epidermal growth factor receptor (HER2)-positive early or locally advanced breast cancer who received 12 weeks of adjuvant or neoadjuvant trastuzumab with paclitaxel and four cycles of an anthracycline-based regimen in either sequence, through a patient assistance program between January 2011 and December 2012, were analyzed for disease-free survival (DFS), overall survival (OS), and toxicity. Results: A total of 102 patients were analyzed with a data cutoff in September 2019. The median follow-up was 72 months (range 6–90 months), the median age was 46 (24–65) years, 51 (50%) were postmenopausal, 37 (36%) were hormone receptor-positive, and 61 (60%) had stage-III disease. There were 37 DFS events and 26 had OS events. The 5-year DFS was 66% (95% Confidence Interval [CI] 56–75%) and the OS was 76% (95% CI 67–85%), respectively. Cardiac dysfunction developed in 11 (10.7%) patients. Conclusion: The use of neoadjuvant or adjuvant 12-week trastuzumab-paclitaxel in sequence with four anthracycline-based regimens resulted in acceptable long-term outcomes in a group of patients, most of whom had advanced-stage nonmetastatic breast cancer.

Access to HER2?targeted therapy at a tertiary care center in India: An evolution

Background:In a previous retrospective audit from our institution we reported that patients had limited access to HER2-targeted therapy due to financial constraints. Subsequently, the advent of biosimilar versions of trastuzumab and philanthropic support has potentially changed this situation. Herein, we reanalyzed and reported access to HER2-targeted therapy in a more recent cohort of patients. Methods: Medical records of new breast cancer patients registered in one calendar year were retrospectively reviewed, supplemented by online pharmacy data to extract information on receptor status, use of HER2-targeted therapy, and other relevant variables. Since not all HER2 immunohistochemistry (IHC) 2+ tumors underwent fluorescent in-situ hybridization (FISH) testing, we estimated the probable HER2 amplified from this group based on a FISH amplified fraction in those HER2 2+ tumors who did undergo FISH. Results: Between January 2016 and December 2016, 4717 new BC patients were registered at our institution, of whom 729 (20.04%) had HER2 IHC 3+ tumors while 641 (17.62%) had HER2 IHC 2+ tumors. The final number of HER2 overexpressing/amplified tumors was estimated to be 928 (729 HER2 IHC 3+, 105 known FISH amplified, and 94 estimated FISH amplified), of whom 831 received treatment at our institution. Overall 474 (57.03%, 95% confidence interval [CI] 53.6–60.4) of these 831 patients received trastuzumab for durations ranging from 12 weeks to 12 months in the (neo)adjuvant setting or other durations in metastatic setting compared to 8.61% (95% CI 6.2–11.6) usage of HER2-targeted therapy in the 2008 cohort. Conclusion: Access to HER2-targeted therapy has substantially increased among patients treated at a public hospital in the past decade, likely due to the advent of biosimilars, the use of shorter duration adjuvant regimens, and philanthropic support. However, further efforts are required to achieve universal access to this potentially life-saving treatment.

Cancer care continuum at a tertiary care centre in India during the Covid-19 pandemic and nationwide lockdown: Healthcare delivery through telemedicine

BACKGROUND The Covid-19 pandemic and subsequent lockdown in India caused disruptions in cancer treatment due to the restriction on movement of patients. We aimed to maintain continuity in cancer treatment during the lockdown through teleconsultations. We tried to reach out to our patients using telephonic consultations by establishing a Teleconsult Centre facility run by a team of doctors and patient navigators. METHODS We telephonically contacted all patients who had outpatient appointments from 23 March to 30 April 2020 at our centre through the Teleconsult Centre to understand their current circumstances, feasibility of follow-up, local resources and offered best possible alternatives to continue cancer treatment, if required. RESULTS Of the 2686 patients scheduled for follow-up during this period, we could contact 1783 patients in 9 working days. Through teleconsultations, we could defer follow-ups of 1034 patients (57.99%, 95% confidence interval [CI] 55.6%–60.3%), thus reducing the need for patients to travel to the hospital. Change in systemic therapy was made in 75 patients (4.2%, 95% CI 3.3%–5.2%) as per the requirements and available resources. Symptoms suggestive of disease progression were picked up in 12 patients (0.67%, 95% CI 0.35%–1.17%), who were advised to meet local physicians. CONCLUSION Our study suggests that the majority of patients on follow-up can be managed with teleconsultation in times of crisis. Teleconsultation has the potential of being one of the standard methods of patient follow-up even during periods of normalcy.

Efficacy of screening cancer patients at hospital entrance for COVID-19 with a questionnaire and thermal scanning: An audit

Objectives: Although commonly practiced, the accuracy, effectiveness, and safety of screening patients for COVID-19 at hospital entrances is not well documented. Material and Methods: We performed a retrospective analysis of single institution data involving screening patients for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection at hospital entrances by trained health personnel, with thermal scanning and administration of a standard questionnaire eliciting risk factors and symptoms of COVID-19. SARS-CoV-2 positivity among patients screened positive and negative and among personnel involved in screening were estimated. Results: Between May 22, 2020, and July 4, 2020, a total of 20152 patients involving 54955 hospital visits were screened at hospital entrances of whom 668 (3.31%, 95% CI 3.07–3.57) were screened positive for suspected COVID-19 and 19484 (96.69%, 95% CI 96.44–96.93) were screened negative. Among patients screened positive, of the 638 patients with available records, 109 (17.08%, 95% CI 14.24–20.23) were confirmed to be SARS-CoV-2 positive by polymerase chain reaction test, 288 (45.14%, 95% CI 41.23–49.10) were negative, 71 (11.13%, 95% CI 8.79–13.83) were not tested after secondary assessment, and 170 (26.65%, 95% CI 23.25–30.26) patients declined the test. Among screen negative patients, 162 (0.83%, 95% CI 0.71–0.97) were SARS-CoV-2 positive. Of the 104 personnel involved in screening, 03 (2.88%, 95% CI 0.60–8.20) were confirmed to be SARS-CoV-2 positive during study period. Conclusion: Screening patients with a combination of thermal scanning and a standard questionnaire for COVID-19 has a high positive predictive value for detecting this infection with low risk of SARS-COV-2 transmission to the involved health personnel

Angelina's choice: private decision, public impact.

The decision of the actress, Angelina Jolie (AJ), to undergo preventive risk-reducing bilateral mastectomy has elicited extreme responses, in support and against. We will discuss whether her decision was justified and if there are other options available to women. AJ, who is 38 years old, inherited the BRCA 1 gene. Because of the lack of randomised trials, there is controversy about the overall benefit that various risk-reduction strategies offer carriers of the BRCA 1, but some of the strategies offer a clear benefit. The decision to opt for mastectomy must be driven by the patient's choice, evidence on the balance of the risks and benefits, the quality of life after surgery and issues relating to body image.

Ethics of “standard care” in randomised trials of screening for cervical cancer should not ignore scientific evidence and ground realities.

We read with interest the recent editorial in the IJME on the ethics of standard care in screening trials for cervical cancer in India. The author takes exception to the fact that three cervical cancer screening studies in India used no screening as the control arm, in spite of evidence that the Pap smear is an effective screening tool. The author argues that the Pap smear should have been the standard arm in these trials, and that it was unethical to “withhold” this screening method from participants in the control arm of the trial. At the outset, we wish to declare a conflict of interest in our response by virtue of being investigators of one of the aforesaid trials, but feel it necessary to clarify certain facts that have been overlooked

Radioiodide uptake and sodium iodide symporter expression in breast carcinoma.

Breast cancer is a common malignancy in women all over the world and novel therapeutic approaches are required for the treatment of patients who become refractory to conventional therapies. Thyroid cancer is being treated successfully with radioiodine since many years. The iodide is transported inside the thyroid epithelial cell via sodium iodide symporter (NIS) which is a trans-membrane protein. The present study was aimed to explore the uptake of radioiodide (RAI) and the expression of NIS in breast tissues of invasive ductal carcinoma patients. Breast tissues from tumor region (Tu-Br) as well as corresponding normal region (N-Br) were collected from patients of invasive ductal carcinoma. In vitro RAI uptake, its efflux and NIS expression were studied. The uptake of RAI (1.98±1.75 ´ 105 cpm/g) in Tu-Br was significantly higher as compared to that observed in N-Br (0.31±0.27 ´ 105 cpm/g) and fast efflux was observed in the tissue samples. NIS gene expression was positive in 41.66% (10/24) samples of Tu-Br. None of the N-Br samples expressed NIS gene. In 14 samples of Tu-Br, RAI uptake as well as NIS expression was studied. In 50%  of these Tu-Br samples RAI uptake as well as of NIS gene expression was positive. The results indicate that RAI uptake is significantly higher in breast tumor tissues as compared to their normal counterpart and in future  radioiodine may be an important agent for treatment of breast cancer.

Rural cancer registry at Barshi, Maharashtra and its impact on cancer control.

Background. The relevance of population-based cancer registries for planning and implementing cancer control programmes cannot be overemphasized. There are some urban registries in India but very few rural registries despite India being predominantly rural. There are several obstacles to setting up a rural registry including lack of cancer awareness in the rural population and inaccessibility of modern medical facilities. The first rural cancer registry was set up in 1987 at Barshi (population 0.4 million) in western Maharashtra by adopting a methodology suitable for rural areas. Methods. The innovative methodology supplemented the usual registry methodology by regular interaction with the community to educate them on warning signals for cancer, raise cancer awareness and motivate suspected individuals to seek medical attention. Cancer detection clinics were held in villages. Results. The reliability indices show that the registry is of an acceptable standard. The registry activity has increased cancer awareness in this population (p<0.01), increased the frequency of early cervical cancers (stages I and IIa) by more than 2-fold during the past 16 years and significantly decreased the relative risk of death (hazard ratio 0.7 [0.5–0.9]). Conclusion. The innovative methodology has facilitated the process of cancer registration in rural areas. It has had a positive impact on cancer awareness, stage at presentation and survival of cervical cancers—the predominant cancer in the area. The registry has created a resource for epidemiological studies in a rural area where national and international studies are currently being undertaken.