A Few Basics on Cancer Trials

Maybe doctors and patients can help each other out.  We do have some locally available cancer trials in phases II-IV in the Philippines. 

Is someone that you know considering participation?  From my own knowledge of what's available hereabouts, current studies are mostly large, pharmaceutical company-sponsored, & international in scope (with a local arm).  Any doctor can refer you to these trials, if they are aware of them.  I hope that the Philippine Society of Medical Oncologists would list them all and post each center coordinator's contact details because there are eligibility issues for enrollment, with study-specific inclusion & exclusion criteria.  (For example, one project requires evidence of chemotherapy-induced anemia.)  Patient care will be coordinated by the study investigators while on the trial, in tandem with the participant's own doctors.  This is a plus– local investigators for the trials are board-certified & respected oncologists based in academic and/or major cancer centers.

Phase II & III trials usually provide both accepted & investigational cancer treatment, as well as all related medical services, laboratory & imaging.  Some phase IV trials give steep discounts (~50%) for the privilege of collecting your data while on standard treatment with their drugs.

As an oncologist, I prioritize these trials but have learned to expect resistance from patients AND doctors.  Misconceptions abound.  The trialists will not supplant the role of the primary physician.  Participants in these studies are not legally compelled to finish the process.  Patient well-being is secured by protocol checkpoints & side effects are minimized by constant protocol reviews.  Both active therapy & follow-up are under the direct supervision of respected oncologists, and their protocols may serve as treatment options where standard therapies don't exist or have run out.  But yes, not all side effects can be foreseen, nor can treatment benefit be guaranteed.  In fact, those issues may be part of the clinical questions to be answered, especially by the earlier phase trials. 

So– don't dismiss these trials upfront, but know what to ask the doctors in charge.  One of the requirements for a patient's enrollment is informed consent after all.

Types of Oncologists & the Team Approach

When it comes to cancer treatment, one of the most frequently asked questions is "What kind of Oncologist should I see?"  There are so many kinds of doctors who describe themselves as oncologists: pediatric, medical, radiation, surgical, gynecologic, neuro- &  psycho-... Which types are formally trained to do cancer surgery? drug treatment? radiotherapy?

Are they interchangeable?  In a word, NO!, and this is true on an international scale.  

Hieronymous Bosch  A barber doing Awake Neurosurgery!

Decades ago, before the advent of complex yet significantly better options, cancer was treated by Jacks- & Jills-of-all-trades.  (In fact, centuries ago, barbers did it all.)  These days, however, the management of cancer has become so complex that one can't reasonably expect a single physician to master the intricacies of each pertinent discipline.  It now takes a multi-disciplinary team to optimize treatment planning.  In such a team, each member brings his or her focused expertise to the table, and all considerations of the represented specialties are discussed.  Differences are threshed out to enable a coordinated "best" plan that is specific to each patient.  The beauty of this is that it actually costs a patient much less to consult such an empaneled team than it would to see each specialist separately.  Soon (where not yet applicable), the laws of supply & demand will move institutions to package their teams' services for the consumers' benefit.

Imagine updating oneself in multiple specialties for, say... Breast Cancer:   new surgical techniques with hands-on training, Mammosite brachytherapy and other recent radiation technologies, the 1001 clinical drug trials for invasive and non-invasive breast malignancies, for pre-operative, adjuvant, and metastatic settings.  Then review the status of each modality every 3 months when you haven't even finished going through the standards you'd started out with.  Now do the same for the different soft tissue sarcomas of the breast. Then all the other cancers possible in humans ....Phew! 

For basic information on oncologists, try these links--

1. Define "Oncologist". Check out your doctor's credentials, not a casual description.
2. "Cancer surgeon" on a card does not imply formal subspecialization. General surgeons hereabouts can claim this title without benefit of certification... and in good faith. There is considerable overlap between the jobs of a general "cancer" surgeon and a surgical oncologist, you see, but its the skills learned from experts where they differ. Just what is the advantage of having a formally trained Surgical Oncologist on one's management team? Its important for you to know what this rare bird can offer.
3. What is the extent of a gynecologic oncologist's duties?
4. The tough job of Pediatric Oncologists
5. What is a Medical Oncologist, & what do they do?
6. Radiation Oncologists vs. the UK's Clinical Oncologists
7. Then there are the "Neuro-oncologists", a very confusing term indeed. The surgical neuro-oncologists are neurosurgeons who have had the benefit of regimented clinical training in the surgical management of brain/spine/nerve tumors. Medical neuro-oncologists, on the other hand, may be neurologists or internist-medical oncologists who are proficient in the medical management of such tumors--ie, by treatment with drugs (vs the knife or radiation).

• From the outset, it is certain that the different neuro-oncologists must work as a team, with each member contributing knowledge from his/her area of expertise. But just who best speaks for each specific area? The fact that some  facilties overseas take on both surgeons amd medical people for non-surgical work in clinical (hands-on with patients) or research (hands-off) jobs in their neuro-oncology units contributes significantly to the difficulties in defining the subsequent roles of their products.   For this reason, the practice is not popular at major training centers.  It would take a wise and conscientious hospital credentials committee to define what a program has prepared a doctor for.
   

As for surgeons who administer systemic chemotherapy when a properly trained specialist is easily accessible in the area, let's just say that, outside of gynecologic oncology, I know of no other area where that practice is considered optimal in this, the 21st century.  Even when I was still in training, surgical oncology trainees at chemotherapy units were just "passing through", just as we had to sit through their hair-raising  audit sessions in similar outsiders' roles.  After all, we were already being trained to deal with each other in a proper context even then.

Deciphering an Oncologist's Credentials

An oncologist is a physician  specializing in the treatment of cancer.  By this definition, you can have a basic science PhD who develops drugs for cancer treatment but is not an oncologist (except for his lab rats).  When the drugs or procedures are finally tried in humans, the clinicians are called in.  Why?  Well, I doubt that even Mme. Curie would’ve felt qualified to plan modern brachytherapy for cervical cancer.

There are all sorts of oncologists.  Their qualifications can be checked with the appropriate subspecialty societies that certify them as such.  Competent certification verifies all training credentials, a potentially litigious process, and administers board examinations only to those who pass scrutiny.  Observership ("hands off"), graduate research fellowships (”lab jobs”), and program interruption aren’t quite the same as completed hands-on clinical instruction.  When granted, formal certification implies that the training facilities & program were adequate, that the candidate applies sufficient knowledge to actual cases, & that he is reasonably updated in his field. 

Certifying bodies, such as those of the PSMO (Medical Oncology), PROS (Radiation Oncology), also police their ranks.  Some other societies function more as interest groups and not as certifying bodies, such as the PSO (Philippine Society of Oncologists).  Anyway, these societies are behind all those letters appended to a doc’s name.  So many F's.  What do they mean? 

• Juan de la Cruz, MD, FPSO.  Dr de la Cruz passed the basic Medical Boards & is an F (Fellow) of the Philippine Society of Oncologists.  He is not necessarily a clinical oncologist.   He could even be a pathologist.
• Jose Juan, MD, FACS.  At the very least, Dr Juan is certified by an accredited surgical society in any country.  The American College of Surgeons does not administer examinations.  Better check what he is actually certified for and by whom.
• Crisostomo Ibarra, MD, FPCS, FPSO.  A certified surgeon.  We can’t tell if he trained for any of the surgical subspecialties but, like many general surgeons, he did join the the Philippine Society of Oncologists.
• Maria Clara, MD, FPCP, FPROS, PhD (Radiation Physics).  Dr Clara is clinician-scientist certified for Internal Medicine & Radiation Oncology, with postdoctoral work in radiation physics.  Among many other things she is an oncologist.
• Ida Rizal, MD, FPCP, FPSHBT.  An internist and hematologist, Dr Rizal is competent with blood-related malignancies like the leukemias too.
• Consolacion Damaso, MD, FPSMO.  Dr Damaso is either modest or lazy.  She is both a certified medical oncologist and internist-- unless she’s old enough to have escaped the requirement for PCP certification (”grandfather clause”) imposed years ago.  Strictly speaking, her credentials are MD, FPCP, FPSMO.
• Pediatric oncologists used to belong to the PSMO when there were but a handful of them, so some senior pediatric oncologists are FPSMO.

Confusing, isn't it?