Adding chemotherapy to hormone therapy helps control locally advanced prostate cancer: Study

For patients with locally advanced prostate cancer, combined treatment with chemotherapy and hormonal therapy offers extended control of prostate-specific antigen (PSA) levels, compared to hormonal therapy alone, reports a study in the April issue of The Journal of Urology®, an Official Journal of the American Urological Association (AUA). The journal is published in the Lippincott portfolio by Wolters Kluwer.

“Our clinical trial is the first to show a longer time to biochemical recurrence with chemotherapy plus standard hormone therapy for patients with locally advanced, high-risk prostate cancer,” comments Jiahua Pan of Shanghai Jiao Tong University, People’s Republic of China. “The findings add new evidence to support the use of combined chemohormonal therapy for a group of patients at high risk of recurrent, progressive prostate cancer.”

Chemohormonal therapy for high-risk, locally advanced prostate cancer

The randomized controlled trial included 141 men with locally advanced prostate cancer, in which cancer has spread outside the prostate to nearby tissues. All patients had clinical characteristics placing them at elevated risk of distant tumor spread (metastasis) after initial treatment.

In a 2:1 ratio, patients were randomly assigned to treatment with the chemotherapy agent docetaxel plus hormonal (androgen deprivation) therapy or hormonal therapy alone. In both groups, these “neoadjuvant” treatments were followed by surgery (radical prostatectomy and extended lymph node dissection).

The study focused on biochemical progression-free survival – control of serum PSA levels – as a sign of tumor control. Rising PSA levels are an early sign of recurrent or progressive prostate cancer. The study also looked at pathologic responses: whether the study treatments were effective in shrinking the prostate cancer before surgery.

Addition of chemotherapy prolongs time to rising PSA levels

Both groups had good pathologic responses: the cancer was “downstaged” before surgery in 65% of patients assigned to chemohormonal therapy and 48% of with hormonal therapy only. The two groups also had similar rates of minimal residual disease – only a small number of cancer cells remaining after treatment.

Chemohormonal therapy had a greater effect on biochemical progression-free survival. At three years’ follow-up, 29% of patients receiving chemotherapy plus hormonal therapy remained free of rising PSA levels, compared to 9.5% with hormonal therapy only.

Median time to rising PSA levels was 17 months with chemohormonal therapy versus 14 months with hormonal therapy alone. Patients receiving chemotherapy also had a higher treatment-free survival rate: 8.5% required no further prostate cancer treatment through five years’ follow-up. The two groups had similarly low complication and adverse event rates.

On its own, neoadjuvant hormonal therapy can improve tumor control in locally advanced prostate cancer, but studies have shown limited effects on patient survival. The combination of docetaxel chemotherapy and hormonal therapy has yielded inconsistent results, likely reflecting differences between studies.

The new study is the first to show improvement in biochemical recurrence rate with chemohormonal therapy in this group of patients. The results also point to possible improvements in other important outcomes.

The authors note that their study is limited by relatively short follow-up times – making it impossible to evaluate the effects on “more clinically significant endpoints,” including overall survival and risk of death due to prostate cancer. “Our study suggests that neoadjuvant docetaxel-based chemotherapy could bring significant improvement for patients,” the researchers write. They emphasize, “longer follow-up is needed for more supportive evidence.”

Reference:

Qian H, Chi C, Tricard T, Zhu Y, Dong L, Wang Y, Sha J, Wang J, Ma Z, Wang Y, Liu J, Dong B, Pan J, Xue W. A Prospective Randomized Trial of Neoadjuvant Chemohormonal Therapy vs Hormonal Therapy in Locally Advanced Prostate Cancer Treated by Radical Prostatectomy. J Urol. 2024 May;211(5):648-655. doi: 10.1097/JU.0000000000003876. 

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Antibiotics may not be effective against cough caused by Acute Lower Respiratory Tract Infections: Study

A recent study evaluates the effectiveness of antibiotics in treating acute lower respiratory tract infections (LRTI) among adult patients in US primary and urgent care settings. Antibiotic overuse remains common for LRTIs, despite evidence suggesting limited benefits and contributing to antibiotic resistance. This study aims to shed light on the impact of antibiotic use on symptom severity and treatment duration for LRTIs.

Researchers have found in a new study that Antibiotics may not be effective against cough caused by Acute Lower Respiratory Tract Infections.The study published in the Journal Of General Internal Medicine was conducted by Daniel J. and colleagues.

The study enrolled 718 adult patients presenting with cough and symptoms consistent with LRTI at primary or urgent care sites across the US. Data collected included demographics, comorbidities, symptoms, and respiratory pathogen testing. Severity of signs/symptoms was reported using diaries and text messages for up to 28 days. Antibiotic use and its effects on symptom duration and severity were analyzed.

The key findings of the study were as follows:

  • 29% of patients received antibiotics at baseline, with common prescriptions including amoxicillin-clavulanate, azithromycin, doxycycline, and amoxicillin.

  • Antibiotic use did not impact the duration or overall severity of cough, regardless of viral, bacterial, or mixed infections.

  • Patients receiving antibiotics were less likely to have a follow-up visit (14.1% vs 8.2%), but were more likely to receive systemic corticosteroids (31.9% vs 4.5%) and albuterol inhalers (22.7% vs 7.6%).

  • Patients believed antibiotics would shorten illness duration by nearly 4 days, despite evidence to the contrary.

The study highlights the limited effectiveness of antibiotics in treating acute LRTIs, with no measurable impact on symptom severity or duration. Moreover, patients’ unrealistic expectations regarding antibiotic efficacy underscore the importance of antibiotic stewardship efforts. Healthcare providers should prioritize educating patients on the appropriate use of antibiotics and managing expectations for LRTI treatment outcomes.

Antibiotics show no measurable impact on the severity or duration of cough due to acute LRTIs, according to a large prospective study in US primary and urgent care settings. Unrealistic patient expectations regarding antibiotic efficacy highlight the need for targeted antibiotic stewardship interventions to optimize treatment strategies and combat antibiotic resistance.

Reference

Merenstein, D.J., Barrett, B. & Ebell, M.H. Antibiotics Not Associated with Shorter Duration or Reduced Severity of Acute Lower Respiratory Tract Infection. J GEN INTERN MED (2024). https://doi.org/10.1007/s11606-024-08758-y

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Delhi Doctor slapped Rs 3 Lakh compensation for not informing patient about treatment complications

New Delhi: The District Consumer Disputes Redressal Forum-II, recently held a Delhi-based doctor liable for a lapse in not informing a patient about the complications of the procedure to treat subacromial bursitis.

“It has nowhere been recorded either in the prescriptions filed on the record or any other document that the complainant was explained the procedure that its known complications since cellulitis abscess, necrotising, fascitis can occur after procedure and is a known complication of the disease subacromial bursitis,” noted the Consumer Court.

For this procedural lapse, the Commission directed the doctor to pay Rs 3 lakh as compensation to the patient, who had to undergo treatment at multiple hospitals after pus started oozing out of her right arm.

The history of the case goes back to 2018 when the patient experienced pain while doing her household chores and office work. The treating doctor, who is also the director of the treating hospital, conducted a physical examination of the patient, administered an injection on her right shoulder and prescribed her further medicines. An X-ray was also conducted.

It was alleged by the patient that before consulting the treating doctor, she was able to perform her daily chores and office work, fulfill her basic personal needs. However, after being treated, she became incompetent to perform all such activities. 

The patient claimed that from the very next day, she developed acute pain in her right shoulder and arm and when she visited the hospital, the doctor allegedly assured her that she would get better and prescribed further medicines. During all this, however, the patient was allegedly not provided with X-ray report and bill receipts. 

Within a few days, she allegedly became unable to lift her right arm due to acute pain and swelling and was taken to Max Smart Super Speciality Hospital, Saket where she was prescribed medicines and was advised to undergo various tests. She was admitted in an emergency as her condition worsened and the pain spread towards the back. Thereafter, the patient was admitted to BLK Hospital for further treatment.

After being treated at the concerned hospital for a few days, the patient’s condition further worsened after discharge and pus started oozing out of her right arm. Due to immense trauma and torture, secretion of pus from her arm, and swelling immobility of the arm compelled her to another opinion at Apollo Hospital, where she was advised to undergo immediate surgery.

Accordingly, she underwent her first surgery on 08.01.2019, another surgery on 01.02.2019, and a third surgery on 04.02.2019. The complainant was discharged on 06.02.2019 after her health stabilized and was given a vac dressing.

In this regard, the complainant relied upon the medical certificate granted by Apollo Spectra Hospital, wherein she was declared medically unfit as her right arm was immobile and even for her personal care and hygiene she needed assistance from an attendant and required a special diet.

The patient submitted that she was again admitted to Apollo Spectra Hospital on 26.02.2019 with a complaint of “FUC and cellulite with raw area arm and shoulder” having surgical history of “intra articular injection on right shoulder on 15.12.2018 and patient developed as pain and swelling on right should and arm 2-3 days after the injection “. It was submitted she was admitted to cover the open wound on the right arm and was discharged on 28.02.2019. 

Claiming that she was unable to attend her work, and incurred huge expenses in managing her day-to-day affair on account of the medical negligence by the doctor and hospital, the complainant filed a consumer complaint and sought Rs 18 lakh as compensation with @18% per annum on account of physical, mental agony, pain sufferings, financial losses, deficiency in service, and unfair trade practice on the part of the hospital and its director. 

She alleged that the doctor performed his duty with the utmost careless manner and indulged in unfair track practice which caused grave injury to the complainant.

On the other hand, the hospital and doctor denied any negligence or deficiency of service on their part. Relying on the Supreme Court order in the case of Martin F D’souza Vs. Mohd. Ishfaq and Jacob Mathew Vs. State of Punjab, the doctor claimed that the diagnosis, disease and treatment and the complications thereafter are a matter of fact and no speculation and the treatment given cannot be garbed as negligence where they tried their level best and used highest degree of knowledge, infrastructure, efforts and precautions to avoid complications.

It was also submitted that even if it was presumed that something went wrong with the treatment, the treating doctor was not a God and could not give surety or guarantee of 100% relief in all cases. Further, the doctor claimed that the patient was explained in detail about the line of treatment, and the actual treatment procedure and therefore unless and until the complainant could prove that the doctor deviated from the normal/prescribed line of treatment no negligence could be inferred against the doctor. The doctor further claimed that he properly examined, investigated, diagnosed, and treated the patient as per the general norms of practice.

According to the doctor, the patient was diagnosed with subacromial bursitis and therefore infiltration locally and all aseptic precautions in the subacromial space were given as per the advice. Anti-inflammatory medicines were prescribed. Therefore, the doctor and hospital denied the allegation that the treatment given to the complainant on her right shoulder downward towards her arm resulted in multiple surgeries or disability in her right arm.

While considering the matter, the consumer court perused the entire medical record and noted that the complainant visited several medical facilities i.e. different hospitals for her treatment. 

“It is difficult to pin point whether there is any medical negligence on the part of the treating doctor of OP-1 as there have been various treatments by various branches of doctors at various other hospitals,” opined the consumer court.

The Commission also noted that the independent medical board opinion received from Safdarjung Hospital also stated that “the complications of cellulitis abcess, necrotising, fasciitis can occur after procedure, these are known complications after injection.”

After perusing the medical opinion received from Safdarjung Hospital and relying upon legal precedence set by the Supreme Court, the Commission noted

“There is no document filed by the complainant wherein it could be proved that the surgery done by the OP was incorrect or without any due diligence.”

“However, it is noticed that it is not the case of the OP nor has he stated in his Reply that he had explained the procedure which he undertook on the complainant. It has nowhere been recorded either in the prescriptions filed on the record or any other document that the complainant was explained the procedure that its known complications since cellulitis abscess, necrotising, fascitis can occur after procedure and is a known complication of the disease subacromial bursitis,” it further observed while holding the doctor liable for not explaining the complications of the procedure.

“This Commission is of the view that medical negligence on the part of the OP-2 is not made out but it has been proved that the complainant was not informed of the complications of the procedure undertaken On her. It is also noticed that though the complainant was not informed of the complications and her condition deteriorated as a complication of the treatment given to her by OP-2. At the same time it is not missed that the complainant added to her own woes by changing doctors and leaving hospitals against medical advice which aggravated her condition. Therefore, this Commission is of the view that there is contributory lack of care on the part of the complainant,” the Commission added.

Therefore, holding the doctor liable for a procedural lapse, the Commission directed the doctor to pay the complainant Rs 3,00,000 as compensation.

“Though a case of medical negligence is not made out against the OP but a case of procedural lapse in not informing is made out against the OP and therefore this Commission is of the view that ends of justice be met by directing the OP 2 to compensate the complainant with Rs.3,00,000/- within three months from the date of pronouncement of this order failing which the compensation amount would be Rs. 3,50,000/-. This compensation amount is given keeping in mind that the road to corrective surgery was delayed by the complainant herself for the reasons best known to her,” it ordered.

To view the order, click on the link below:

https://medicaldialogues.in/pdf_upload/delhi-dcdrc-236577.pdf

Also Read: Misdiagnosis, prescribing wrong dosage, forging of records: Doctor, Hospital slapped Rs 17 lakh compensation

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Submit post-marketing safety data of Belumosudil in Chronic graft versus host disease: CDSCO Panel Tells Sanofi

New Delhi: Responding to the proposal presented by the drug major Sanofi to import and market Belumosudil tablets 200 mg, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the firm to submit the post-marketing safety data of Belumosudil from all the countries where the drug is approved for marketing.

This came after the drug maker Sanofi presented the proposal for the grant of permission to import and market of drug Belumosudil tablets 200 mg with local Phase III clinical trial waiver along with a request to consider Belumosudil as an Orphan drug as defined in NDCT Rules 2019 as the Chronic graft versus host disease (GvHD) is a rare condition affecting less than 1000 patients in India.
Belumosudil tablets 200 mg are approved in the US, Canada, Great Britain, Australia, China, and Israel. Belumosudil is designated as a breakthrough therapy by the US FDA and also granted priority review in the US and Canada.

Belumosudil is an oral inhibitor of rho-associated coiled-coil-containing protein kinases (ROCK) used in the treatment of chronic graft-versus-host disease (GVHD).

Graft-versus-host disease (GvHD) is a systemic disorder that occurs when the graft’s immune cells recognize the host as foreign and attack the recipient’s body cells. “Graft” refers to transplanted, or donated tissue, and “host” refers to the tissues of the recipient. It is a common complication after allogeneic hematopoietic stem cell transplant (HCT)

Belumosudil is indicated for the treatment of chronic graft-versus-host disease (GVHD) in adult and pediatric patients 12 years of age and older following failure of at least two other lines of systemic therapy. Chronic graft-versus-host disease (GVHD) is a life-threatening complication of allogeneic hematopoietic stem cell transplantation in which the transplanted donor T-cells recognize the recipient’s tissues as foreign and mount an immune response.

At the recent SEC meeting for Haematology held on 19th March 2024, the expert panel reviewed the proposal presented by the drug major Sanofi for the grant of permission to import and market Belumosudil tablets 200 mg with local Phase III clinical trial waiver along with a request to consider Belumosudil as an Orphan drug as defined in NDCT Rules 2019.
After detailed deliberation, the committee opined that Chronic graft-versus-host disease (GvHD) is a rare condition and there is an unmet need in the country.
However, the committee opined that: –
1. The firm should submit the post-marketing safety data from all the countries where Belumosudil is approved for marketing.
2. The firm should submit proper interventional Phase IV clinical trial protocol with adequate methodology and sample size.
Accordingly, the expert panel suggested that the firm should submit the post-marketing safety data of the drug Belumosudil from all the countries where the drug Belumosudil is approved for marketing and Phase IV clinical trial protocol before the committee for further consideration.

Also Read:Eli Lilly Gets CDSCO Panel Nod To Market Mirikizumab for ulcerative colitis in adults

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Study shows experts rate influenza as the number one pathogen of concern of pandemic potential

New research presented at the ESCMID Global Congress (formerly ECCMID) in Barcelona, Spain (27–30 April) shows that in a VACCELERATE Consortium survey study in which infectious diseases experts were asked to rank pathogens in order of their pandemic potential, influenza was considered the pathogen of highest pandemic risk, with 57% ranking influenza as number one, and a further 17% ranking it second.

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H. pylori testing feasible for people in community settings

Community Helicobacter pylori (HP) testing in high-risk individuals is technically feasible, according to a study published online April 3 in Clinical Gastroenterology and Hepatology.

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Sugar cravings could be caused by loneliness, study finds

If you’ve spent a lonely night at home eating chocolates and/or ice cream, you shouldn’t feel guilty. That’s because loneliness can cause an intense desire for sugary foods, a new study found.

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Postpartum low-dose esketamine aids moms with prenatal depression

A single low dose of esketamine after childbirth reduces depressive episodes at 42 days postpartum among mothers with prenatal depression, according to a study published online April 10 in The BMJ.

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Occupations that are cognitively stimulating may be protective against later-life dementia

People with a history of cognitively stimulating occupations during their 30s, 40s, 50s, and 60s had a lower risk of mild cognitive impairment (MCI) and dementia after age 70, according to a new study from Columbia University Mailman School of Public Health, the Columbia Aging Center, and the Norwegian Institute of Public Health. The findings highlight the importance of cognitive stimulation during midlife for maintaining cognitive function in old age.

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AIIMS Kalyani To Conduct Interviews for Externship Program for July-December 2024 Session, details

West Bengal- All India Institute of Medical Sciences (AIIMS), Kalyani is going to conduct interviews for the Externship Program in various departments of AIIMS, Kalyani, West Bengal for the July-December session, 2024. On this, AIIMS, Kalyani has issued a notice detailing the application process, fee, mode of selection, etc.

The Observership or short term training of external students are termed as externship

HOW TO APPLY

Interested candidates will have to fill out the Google form and also attach the necessary documents with it, the link to the Google form is given in the notice. Candidates are advised to fill up each & every column of the application form & read the instructions/ guidelines carefully before filling up the form. Incomplete applications will be rejected straightaway. The application form is available till 30th April 2024 till 05:00 PM. No hard copy of the application would be accepted.

FEE

Only selected student has to deposit the stipulated course fee of Rs.1000/month to the Academic Section through Demand Draft only as per the prescribed norms before starting the externship. The same will be deposited by the academic section to the Accounts section following the direction of the competent authority.

MODE OF SELECTION

Following the shortlisting/verification of applications received the eligible candidates will be called for an interview. The selection of the candidates will be based on their performance in the interview only.

The interview for the Externship Program will be held at the Administrative Building, Ground Floor, Welcome Centre, AIIMS, Kalyani, West Bengal. However, the date and time will be notified on the AIIMS Kalyani official website soon.

IMPORTANT POINTS

1 Any student pursuing graduate/ PG courses of any particular institute of state government or central government or NAAC accredited reputed private institute will be eligible to apply for this externship program for a minimum of one month and a maximum of six months.

2 Candidates have to submit their applications along with the Authorisation letter while addressing the Executive Director of AIIMS, Kalyani from the institute authority where the student is actively pursuing the course. Students who have passed out or appearing for the examination are not allowed.

3 In any case neither the present institute of the student nor the candidate can write directly to any department concerned where the candidate is interested in undergoing an externship.

4 Eligibility of a candidate for externship does not automatically entitle them for selection.

5 Applicants who have previously received training/externship at AIIMS, Kalyani may not be considered for again.

6 On successful completion of the training period, candidates will be issued a certificate of attendance and course completion by the academic section after due approval from the competent authority. Certificate of Attendance will be issued for fulfilling the requirements of the course pursued by the student. Any department of AIIMS Kalyani will not issue any certificate to this effect

7 The Institute does not provide any hostel accommodation for the externship program.

To view the notice, click the link below

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