Adjuvant Chemo for node negative intermediate risk patients (early stage breast cancer)

Dear all,

I recently gone through the NCCN recommendations for adjuvant chemotherapy for early breast cancer (non metastatic disease).

The adjuvant chemotherapy regimens mentioned for early breast cancer (non metastatic disease) are divided into “preferred” and “other regimens”, but the guidelines says that these chemotherapy regimes are not stratified as per lymph node criteria. Hence lymph node criteria has not been taken into account while mentioning the regimens. Additionally if you read the regimen description in the discussion section, you will find that most regimens are outcome of clinical trials involving node positive or high risk node negative disease (most regimens are outcome of node positive disease only). What is the criteria to define high risk node negative disease ?

If we use St Gallens criteria, the patients can be divided as low risk, intermediate risk and high risk group depending upon parameters like lymph nodes, ER/PR status, Her2 status, tumor size, grade, age etc.

I guess low risk patients can safely avoid chemotherapy and for high risk patients, chemotherapy is highly indicated.

But how to consider a patient with intermediate risk (given lymph nodes are negative- with non metastatic disease) ?

Anthracyclins are highly indicated in node positive patients as per NCCN guidelines. Can node negative patients safely omit anthracyclins (considering their long term and short term toxicity) ?

Can intermediate risk, node negative patients be managed just by taxanes only ? (obviously Herceptin will be added with taxane if tumor is Her2 positive)

Or should intermediate risk node negative patients receive full blown chemotherapy (AC-TH) or TCH [both of the regimens are mentioned as “preferred” as per NCCN] ?

Is there any other guideline which stratify chemo regimens as per lymph node criteria (for early stage breast cancer - non metastatic disease) ?

Thank you…

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  • You have done quite a bit of reading, I appreciate that. You have read very well and I can see you have understood all that very well too. Keep it up.

    1. The criteria to decide high risk node negative disease include tumour grade, lympho vascular emboli, perineural invasion, type of cancer (ER positive or HER 2 positive or TNBC), patient's age etc, like you have mentioned in St. Galen's criteria. But all these criteria are not fool proof. For node negative ER positive patients, there is a test called Oncotype Dx which is a gene assay, that determines need of chemo or not. Many Oncologists believe and many don't; it costs 2 Lakh rupees.

    2. Yes, intermediate risk, node negative patients can be managed with taxanes only. (TC)

    3. No other guidelines which stratify.

    Remember, guidelines are only to help an Oncologist offer a choice and patient accept a choice. Every cancer patient's treatment is individualized. For two different patients of the SAME age and exactly the SAME stage of cancer and SAME characteristics, the treatment decided could be different based on various assessments. This is the very reason, that when more than half the users post reports and ask us the treatment further, we have only one thing to tell them "Cancer patients treatment is individualized. Just a few papers containing reports cannot be used to answer questions on decisions of treatment. We need to assess patient, assess physically, assess all past reports, assess general reports and then come to cancer reports and then give judgement. If one could just read a pathology report and give judgement, the total study of Oncology would not take 14 years. There is more to it than you can think"

  • RISK CATEGORIES FOR LYMPH NODE NEGATIVE BREAST CANCER

    Adverse Prognostic Factors:

    1.Age < 35 years

    2. HER2 over-expression (HER2+)

    3. Presence of lymphovascular invasion

    4. Grade 3

    5. Hormone receptor negative disease

    6. OncotypeDx® Recurrence Score ≥31

    Lower Risk

    ≤ 2 cm, grade 1, with no other adverse prognostic factors

    < 0.5 cm with any other feature

    OncotypeDx® recurrence score <18*

    Intermediate Risk

    All other combinations of factors that do not fit into either the low or high risk

    criteria

    OncotypeDx® recurrence score 18-30*

    Higher Risk

    > 1 cm with any 2 or more adverse prognostic factors

    > 2 cm with any 1 or more adverse prognostic factors

    > 3 cm +/- adverse prognostic factors

    Any patient with HER2+ breast cancer

    OncotypeDx® recurrence score ≥31*

    As per treatment, I absolutely agree with Sumeets time and again statement, which he has been advocating everytime.... but people dont understand its significance:

    "Cancer patients treatment is individualized "

    Let me elaborate this point:

    Please note : ( the risk factors remaining same)

    For a 70 year old xyz risk patient : Treatment may not be the same as a 45 year old xyz risk patient

    For a 45 year old abc risk patient with heart problem may not be the same as a 45 year old abc risk patient with no heart problem

    For a 55 year old prq risk patient living in far off village in Jumritalia may not be the same as a 55 year old patient living in Mumbai

    For a 44 year old lady with 10 lakh insurance with abc risk may not be same as a 44 year old lady with abc risk unaffording goverment sector patient.

    For a 65 year old lady living alone with xyz risk may not be the same that of a 65 year old lady living with her sons, daughter and huband, and inlaws and chachas and fufas etc

    There are numerous factors which sway the pendulum of treatment with affordability, toxicity, patient comorbidities, doctor experience, doctors risk taking abilities, the cancer setup whether nursing home or tertiary centre setup.....

    All need to be weighed up... the golden rule is that There should ideally be ZERO mortality with Adjuvant Chemotherapy .

    Primum non nocere:

    Do no harm first, treat the patient after that.

    Sumeets second statement :

    Guidelines are just to Guide the physicians but by no means they are pathar ki lakeer.

    This is also absolutely true and perhaps i need not give a demo for this .....

    A doctor in his first 5 years does not understand these 2 rules and one would try to fit everything like a jig saw puzzle, no space should be left or no peices of the puzzle should be left, the crossword should be full. But in Oncology, when one deals with real lives, these principles are not valid : Life is not maths....

    With experience and maturity, one learns this 2 principles

    Its clinical Judgement.... whether i use anthracyclines or taxanes or a combination

    there will be evidence to back up with almost everything provided its done reasonably.

    Cheers

    Dr Rohit Malde

  • Wonderful elaboration, Rohit. We are indeed privileged to have You on this forum.

  • Thank you Dr. Sumeet and Dr. Rohit for providing a detailed insight into the subject matter.

    And I loved the RULE - "Do no harm first, treat the patient after that".

    Indeed both of you are doing an excellent job in guiding patients and their care givers.

    Regards....

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