Tag Archives: PRO

GOC2: A PRO study on open vs. minimally invasive endometrial cancer surgeries

MDedge and MDLinx separately alerted me to a very interesting study based on GOC 2 (Gynecological Oncology), a Canadian research program. In this particular study (cost comparisons  apparently will be reported separately – MDedge has a video of an interview of the study lead), open surgery for Endometrial Cancer was compared to laparoscopic and robotic surgery techniques. The study was reported at the Society of Gynecologic Oncology 2017 Meeting.

This study is another example where women were recruited across multiple sites, and they answered survey questions, and thus, is a Patient Reported Outcomes (PRO) study on Quality of Life (QOL) following procedures of varying invasiveness.

As a reference, Endometrial Cancer represents about 3.6% of all new cancer cases in the US, occurring as new cases in an estimated 61,380 women in 2017, with a projected mortality for about 10, 920 women. The 5 year survival rate is approximately 81.3%, making Quality of Life an important concern for survivors. An NCI link is available below if you wish to explore more.

The Current Study

Patients with confirmed stage I or stage II endometrial cancer  were recruited across 8 centers in Canada. 106 patients from the open surgery arm, and 414 from the minimally invasive surgery arm participated, with the breakdown amounting to 168 laparoscopic and 246 robotic surgery patients.

Approximately 80% of patients completed the QOL questionnaires. Only about 25 – 50% of the patients responded to the sexual-function questionnaires. Those responding were found to be young, pre-menopausal and sexually active.

The study itself was not randomized, but adjustments were made to accommodate this.

Also, quoting Dr. Ferguson from MDedge below, about sexual function:

Both of the surgical groups “met the clinical cutoff for sexual dysfunction” on the Female Sexual Function Index questionnaire, she said.

Results

The results can be viewed as three distinct sets:

  1. There was no statistical significance in QOL or sexual function, between laparoscopic and robotic procedures.
  2. At 3 weeks, patients in all groups fared better in terms of pain, but Quality of Life was worse for Open Surgery Patients. Novel to this study, this extended to the 3 month period as well, both clinically and statistically. (Please watch video on the MDedge link)
  3. While fewer patients responded to the questionnaires on sexual function, there was no significant difference between the open and minimally invasive surgery groups for up to 26 weeks. I am puzzled by this honestly. If you have reduced Quality of Life, your sexual function ought to be reduced. If it is not, then how would you have a significant difference in one case and not the other? The lower number of responses might be the confounding factor here, and honestly as the paper sits behind a paywall, there is only so much I can glean from reading articles and the abstract.

References:

  1. The MDedge Article (along with the video): http://www.mdedge.com/oncologypractice/article/134206/gynecologic-cancer/video-pain-and-impaired-qol-persist-after-open
  2. Abstract 51 from SGO: https://www.sgo.org/wp-content/uploads/2016/12/SGO-AM17-abstract_titles.pdf
  3. Some Endometrial Cancer Statistics: https://seer.cancer.gov/statfacts/html/corp.html
  4. Image Courtesy of Pexels: https://www.pexels.com/photo/woman-sitting-by-the-seashore-during-day-89820/

Some results on breast reconstruction following mastectomy

The Preface

One of my life goals, and specifically, as it pertains to this site, is to spread the news about free and open, well composed, peer-reviewed scientific publications. Following that tradition, today’s blog focuses on another key area of women’s health – breast cancer, mastectomy and post-mastectomy reconstruction.

The Paper

ASCO and MedPage Today are reporting this paper in the Journal of Clinical Oncology, available on MedPage Today for free (link below), that highlights one year, post operative patient survey results, that highlight differences in satisfaction with breasts, among women who opted for two forms of breast reconstructive surgery.

The two forms are Autologous Recovery or Flap Recovery and Implant Reconstruction.

Autologus Recovery

Autologous Recovery, as some of you might guess, involves tissue from the patient’s own body, reconstructed and used as breast tissue. There are two types of tissue recovery possible: free flap, where the tissue is severed from its blood vessel connections and moved or, a pedicled flap, where the blood vessels are still attached as the tissue is moved. Tissue usually arises from areas such as the belly or the back. A link with details is supplied below.

Implant Reconstruction

Implant reconstruction doesn’t last a life time, the key difference between this and autologous recovery, and may need multiple surgeries. Usually composed of silicone and saline, these implants are sized and implanted into the body. This method is less invasive, and easier with delayed reconstructive options, and provides the patients with multiple breast shape options, allowing for the most suitable form to be chosen and used. Formerly, this was the best option for women with smaller breasts, because they also usually had less tissue available for reconstruction, but autologous recovery has made strides in this area, so this is no longer seen as a big advantage. Refer to the link below for more information.

The present study

The present study enrolled a large number of patients, 1632, in total, across 11 sites; that were undergoing immediate postmastectomy reconstruction for either invasive cancer and/or carcinoma in situ. There is some argument over whether carcinoma in situ is actually cancer. Regardless of the status of this debate, this is the title for a group of cells/tissue that is precancerous and has not metastasized but is expected to. This is common in breast and a few other cancers, and patients many times choose to undergo mastectomy to fend off cancer.

Patient Reported Outcomes (PRO)

The study was conducted by evaluating Patient Reported Outcomes, also known as PRO. This is a method where validated questionnaires are used, to assess treatments and/or symptoms, from the patients’ perspectives, going beyond clinical measurements, which, for the longest time where the mainstay of medical comparative evaluation. There are barriers to the prevalence of PROs, as internet access, data availability, etc. remain challenges, however it is becoming an accepted research form, especially where patients themselves would be the best judges of outcomes.

Care must be taken when interpreting patient reported outcomes, valuable as they are, and especially so, when using them for labeling claims. The FDA has also weighed in.

In this study, using  a generic PRO measure, Patient-Reported Outcomes Measurement Information System–29, patients were quizzed before, and one year after surgery. If you want to read and learn more about PROMIS, I have appended a link below.

The Results and Conclusions

Using the scoring system, and based on the response of 1183 patients, the researchers concluded that patients with Autologous Recovery/Reconstruction had better satisfaction  with their breasts and mental well being. Anxiety and depression were reduced in both groups, however, neither group had fully recovery of chest health. There was increased pain with Autologous Recovery, while patients with Implant Reconstruction had reduced fatigue. overall, it appears patients who underwent Autologous Reconstruction had a slight edge. I have attached links to the summary and the article below.

References:

  1. The ASCO study summary: https://www.medpagetoday.com/reading-room/asco/breast-cancer/64962?xid=NL_ASCORR_2017-05-11&eun=g5100781d39r&pos=1111 Note: The full paper link is available on the same page. 
  2. Autologous Recovery: http://www.breastcancer.org/treatment/surgery/reconstruction/types/autologous
  3. Implant Reconstruction: http://www.breastcancer.org/treatment/surgery/reconstruction/types/implants
  4. PROMIS: http://www.nihpromis.com/?AspxAutoDetectCookieSupport=1#1
  5. A Paper on Patient-Reported Outcomes: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3227331/
  6. Carcinoma in situ: https://www.cancer.gov/publications/dictionaries/cancer-terms?cdrid=46488
  7. FDA Guidance on the use of Patient-Reported Outcome Measures: https://www.fda.gov/downloads/drugs/guidances/ucm193282.pdf
  8. Image Courtesy, Pexels: https://www.pexels.com/photo/flower-pink-peony-blouse-112324/