Head and Neck cancer....
Tuesday was the last ASCO day...
There were several consecutive presentations for h/n, a study done in Hong Kong, one in Singapore, a retropsective analysis of h/n treatment and progress in the Western Hemisphere by Dr. Langer and 2 by IMCL, one P3 and one P2...all presentations by chief PI of the trials...I will report them sequentially as presented at the conference...
Moderator was Dr. Pinto who started by thanking everyone who stayed for the last oral presentations. "Since this is the last one, we can take our time, have more meaningful questions and debate because there's nothing next." Laughter by audience of standing room only, people lined all around the perimeter, media parked in the back with video cameras lined up...I arrived early and had a comfortable seat in the front.
Some history given by Dr. Nancy Lee of Sloane-Kettering in NYC.
In 1896 first RT for pain in the nasopharyngeal and h/n cancer population...1900-1920 RT not considered for treatment(did not detail why)...1921-1950, brachytherapy and 200kilovolt teletherapy.
1951-1970 Cobalt RT 60Gy
Early 1970's chemo added ...
They also showed a map of the incidence of nasopharyngeal and h/n cancer...all of East Asia 'lit up' in red...there are around 500,000 yearly new cases of h/n cancer in the world...NorthAmerica with about 45K yearly, Europe,...the majority of the rest in Asia...Lee of Hong Kong, described it as an epidemic cancer in her region.
Abstract 5506 Dr. A.W. Lee of Hong Kong presented a prosectively randomized study on therapeutic gain achieved by addition of chemo-therapy for T1-4N2-3M0 Nasopharyngeal Carcinoma(NPC)Background...to evaluate exact magnitude of benefit and late toxic effects....Her concern was that the data for distant control and late toxicity was not adequately evaluated and hence, her reason for the project.
I won't take up the threads time to narrate this very detailed analysis of this study...RT vs.Chemo+RT(CRT)... doses of Cisplatinum per Western standards were used. Slides detailing every aspect of the whole study... subgroup distribution of disease stage for both arms, pt. age, therapy, tables of when toxicities, deaths, patient withdrawals from study, etc., all in both arms, ...Latest results reviewed by Independent Data Monitoring Committee in January 2003 and recommendation was to proceed until 5 more of the 335 goal were accrued. Endpoints...FFS(failure free survival) defined as time to first failure at any site or death due to any cause. Secondary, overall survival(OS), disease(DSS) specific survival, and toxicities both early and late...to achieve 80% power for detecting a 15% difference in FFS, target accrual is 340.
Results: 1999-to Nov 2003, 335 patients accrued. The 207 evaluable patients presented and was reviewed by IRB in January 2004...
Discussion of results by Dr. Lee(lead author)...provided slides for every variable, time frame, toxicities with subgroup analysis and distribution of patients in both arms...stage of illness, age, etc...and also showed how the study inadvertantly was over-represented with the more resistant Kerotonizing type of NPC...
Results: 50% of CRT group actually completed protocol...
she provided slides to conclude that death rate of CRT was slightly higher p=0.26, failed to achieve distant control of lesions. Survival data thus far shows no benefit but too early to provide #'s...Progression free survival statistically insignificant(quite honestly, because at this point, we in the west already know the poor survival benefits of patients treated with this protocol, I not write down all exact #'s)...I'm reporting what the presenter said...She concluded with: CRT significantly improved locoregional control but not distant control., CRT group with higher incidence of late toxicity...hearing loss most common.. PFS not significant, but data tentative and still early to make definitive conclusions...
Q&A: several regarding different subgroup findings which she answered directly and knowledgeably, she was given suggestions for analysis as study and data mature...One person(me) asked about the cultural perceptions, population attitudes about chemo and radiation acceptance, perception of clinical trials and if it impacted accrual and compliance and whether it differed with the experience of her Western colleagues...She responded..."in contrast to Western culture where people take chemo even if it gives you just one month survival advantage, people in Hong Kong are more afraid of chemo. More hesitant to take it fearing it will make them worse, they are more accepting of RT...no problem accruing for clinical trials, but more likely to discontinue earlier than Western counterparts......
The second study presented by a Singapore group...differed from Lee's study in that they excluded the more resistant Kerotonizing type of cancer....CRT with cisplatinum and 5FU and cisplatinum adjuvant compared with RT only...56% completed the CRT but most did not receive adjuvant cisplatinum...most common reasons...chemo related side effects of nausea, vomiting, fatigue...
Disease free survival 76% vs. 59% p=0.027
2 year survival 84% vs. 77% p=0.006
Author concurred with Lee that patients were unwilling to to tolerate debilitating side effects...therefore low overall compliance...especially in adjuvant phase but felt his study showed that pts with the non-kerotonizing type did fare better....
cont'd
Zeta |
