本帖最后由 choi 于 5-30-2017 16:26 编辑
It is 8:30 pm, Tuesday, May 30. The cn.nytimes,com has not translated it.
Sui-Lee Wee, Life-or-Death Medical Tourism; Wealthy Chinese look abroad for critical care to avoid their overburderned health system. New York Times, May 30, 2017.
https://www.nytimes.com/2017/05/ ... urism-hospital.html
Excerpt in the window of print: Better care, but challenges upon return
Note:
(a) Guo Shushi's (Sing Tao Daily: 郭树实) stomach cancer (medical term: gastric cancer) "roared back even after Mr Guo, a 63-year-old real estate developer, endured surgery, chemotherapy and radiation at two hospitals [in China]. * ** Mr Guo was at the Dana-Farber Cancer Institute in Boston, receiving a new immunotherapy drug, Keytruda, which is not available in China. In April, nearly four months later, his tumor has shrunk and his weight has gone up. * * * The cost: about $220,000 — all paid out of pocket [because Mr Guo does not have health insurance]."
Regarding Keytruda, a Merck trademark for pembrolizumab (a monoclonal antibody against PD-1). The latest development first.
(i) The drug is so new, there are few medical reports on its effectiveness -- certainly not on gastric cancer.
Press release: Data for KEYTRUDA® (pembrolizumab) Across 16 Types of Cancer from Merck's Industry-Leading Immuno-Oncology Program to Be Presented at the 2017 ASCO Annual Meeting. Merck, May 17, 2017
http://investors.merck.com/news/ ... eeting/default.aspx
(Merck "today announced that new and updated data from studies of KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, will be presented at the 53rd Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, June 2 – 6, 2017. At this year’s meeting, researchers will present data from more than 50 abstracts investigating the use of KEYTRUDA as monotherapy and in novel combinations across 16 cancers, including non-small cell lung cancer (NSCLC), melanoma, urothelial carcinoma, microsatellite instability-high (MSI-H) cancers, gastric cancer and breast cancer. Additional longer-term progression-free survival (PFS) and overall survival (OS) data for KEYTRUDA in monotherapy and as a combination therapy in first-line NSCLC from KEYNOTE-024 and KEYNOTE-021G will be presented")
(A) progression-free survival (PFS)
NCI Dictionary of Cancer Terms (NCI stands for US National Cancer Institute), undated.
https://www.cancer.gov/publicati ... r-terms?cdrid=44782
(B) https://www.cancer.gov/publicati ... =overall%20survival
(2 results found: overall survival and overall survival rate)
(ii) On Sept 4, 2014, US Food and Drug Administration (FDA) approved its use to treat advanced melanoma (there were detailed indications that I will not go into). (On Dec 22, 2014 FDA approved a similar monoclonal antibody nivolumab (Opdivo; Bristol-Myers Squibb) to treat the same.)
(iii) So far, FDA has approved Keytruda, alone or in combination with other drug(s), to treat melanoma, non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), Hodgkin lymphoma, urothelial carcinoma, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors or colorectal cancer, See
Keytruda Is Now Approved in 9 Indications.
https://www.keytruda.com/hcp/
(A) Take notice Gastric cancer is not one of them. In other words, FDA has not approved Keytruda treat gastric cancer. That is why, Aetna in a policy statement says Keytruda's use in gastric cancer patients is experimental, see Pembrolizumab (Keytruda)
www.aetna.com/cpb/medical/data/800_899/0890.html
("Aetna considers pembrolizumab (Keytruda) experimental and investigational for all other indications including the following (not an all-inclusive list):" gastric cancer among others (such as breast cancer) )
, and the cost will not be covered -- even for its policy holders in US.
(B) Indeed Merck on May 23, 2017 (a week ago) has a press release titled "FDA Grants Priority Review to Merck's Supplemental Biologics License Application (sBLA) for KEYTRUDA® (pembrolizumab) for Treatment of Recurrent or Advanced Gastric or Gastroesophageal Junction Adenocarcinoma."
(C) The only medical report I can find of Keytruda in treating gastric cancer is
Muro K et al, Pembrolizumab for Patients with PD-L1-Positive Advanced Gastric Cancer (KEYNOTE-012): a multicentre, open-label, phase 1b trial. The Lancet, 17: 717-726 (June 2016)
thelancet.com/journals/lanonc/article/PIIS1470-2045(16)00175-3/fulltext
("all [39] responses were partial. All 39 patients were included in the safety analyses")
This is a phase 1 clinical trial to assess whether a new drug is toxic to patients, not its effectiveness (which would be addressed in phases 2 and 3), Besides, patients got "partial" improvement, meaning the cancer might shrink but not vanish.
The clinical trial was called KEYNOTE-12, much like law enforcement or the military use "Operation so-and-so."
(iv) Even for treatment of a FDA-approved cancer (NSCLC), improvement in patients is statistically significant, but only measured by months.
Reck M et al, Pembrolizumab versus Chemotherapy for PD-L1–Positive Non–Small-Cell Lung Cancer. New England Journal of Medicine, 375: 1823-1833 (November 2016)
http://www.nejm.org/doi/full/10. ... =featured_home&
("Median progression-free survival was 10.3 months * * * in the pembrolizumab group versus 6.0 months * * * in the chemotherapy group [conventional treatment as the control] * * * The estimated rate of overall survival at 6 months was 80.2% in the pembrolizumab group versus 72.4% in the chemotherapy group")
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