NSCLC guidelines for the treatment of 2016V4: maintenance therapy, NCCN

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Non-Small Cell Lung Cancer non small cell lung cancerNCCN Guidelines Version 4.2016 NCCN guide 2016 edition fourthDiscussion discussionTreat


Non-Small Cell Lung Cancer non small cell lung cancer

NCCN Guidelines Version 4.2016 NCCN guide 2016 edition fourth

Discussion discussion

Treatment Approaches treatment

Maintenance Therapy maintenance therapy


Therapy refers to therapy may be given for patients systemic that with

Advanced after 4 to 6 cycles first-line chemotherapy. maintenance therapy is a systemic treatment that may be given to patients with advanced NSCLC after first-line chemotherapy in the period of 4 to 6 cycles (NSCLC).


Patients are candidates for therapy if they only maintenance have

Responded to previous treatment (ie, tumor response) or their have

Stable disease their tumors have not and progressed.

However, it is only suitable for patients who have had an immediate response to their previous treatment (i.e., remission of the tumor) or stable disease and progression of the tumor.

Continuation maintenance therapy to use of least one the agents that was given in the at first-line regimen. of the refers

Maintenance therapy is the use of at least one drug given in a first-line regimen.


Maintenance (category 2B) therapy to initiation the of refers a

Different agent that not as part of the first-line was included regimen.

Conversion maintenance (class 2B) treatment refers to the initiation of a different drug, that is not included in the first part of the program.


Depends appropriate therapy on several factors (eg) of maintenance,

Histologic type, presence of or gene rearrangements, PS) in

The choice of appropriate maintenance therapy depends on several factors, such as histological type, presence of mutations or gene rearrangements, PS).


Therapy is an in NCCN Guidelines for select patients option the with

Tumor response or disease is not considered the standard stable and of

Care for patients (eg, not for PS 3 - 4, those with) recommended all

Progression); close observation (category 2A) is a valid also treatment

Option (see the Guidelines for Cell Lung Cancer) in (NCCN)

In NCCN, for all of the selected tumor effective or stable disease, and do not consider the standard of care for patients (e.g., for PS 3 - 4, progress is not recommended), maintenance therapy is a kind of choice; close observation (2A) is an effective treatment option (see non small cell lung cancer NCCN guide).

Continuation Maintenance Therapy

Continued treatment


Continuation maintenance therapy, select agents (which were initially)

Given in combination conventional chemotherapy) may be with continued

Until evidence disease progression unacceptable toxicity, as of or per

The design the clinical that led to their of trials approval.

For continued treatment, according to the approved clinical trial design, the selected drugs (given in the initial combination of traditional chemotherapy) can continue until evidence of disease progression or unacceptable toxicity.


Bevacizumab (Category 1) may continued beyond 4 to 6 cycles be of

Initial therapy (ie, platinum-doublet chemotherapy given with)

In (bevacizumab) patients with NSCLC who are negative non-squamous for

ALK rearrangements sensitizing EGFR or mutations.

In the ALK rearrangement or sensitive EGFR mutation negative non squamous NSCLC patients, in the initial 4 to 6 cycles of treatment (i.e., platinum based chemotherapy and bevacizumab) outside can continue bevacizumab (1 class).


Pemetrexed (Category 1) may be given as continuation also maintenance

Therapy in with non-squamous NSCLC (who are negative for ALK) patients

Rearrangements or sensitizing mutations EGFR)

In patients with non squamous NSCLC (ALK rearrangement or sensitive EGFR mutation negative), can also be given single drug pemetrexed (Level 1) as a continuation of treatment.


Recent phase 3 randomized trial (PARAMOUNT) found that continuation

Maintenance therapy pemetrexed slightly PFS when increased with compared

With placebo (4.1 vs. 2.8 months)

A recent phase 3 randomized trial (PARAMOUNT) found that pemetrexed continued to maintain a slight improvement in PFS (4.1 versus 2.8 months) compared with placebo.

Results show continuation maintenance with also improves survival overall (13.9 vs. 11 months) in, therapy

The results showed that pemetrexed maintenance therapy also improved overall survival (13.9 versus 11 months).


On the trial and FDA approval, the NCCN Panel recommends the recent

Single-agent pemetrexed continuation maintenance therapy (Category 1) (as)

In patients non-squamous NSCLC without ALK rearrangements with but or

Sensitizing EGFR mutations.

Based on recent trials and the approval of the FDA, the NCCN team recommended the use of pemetrexed alone as a non - NSCLC but not ALK - or EGFR - sensitive mutation in patients with maintenance therapy (Category 1).


Maintenance therapy cetuximab was removed from the with recently NCCN

Guidelines, because first-line regimen the of

Cetuximab/cisplatin/vinorelbine was removed (see Cetuximab in this)


Cetuximab continues to be treated as recently removed from the NCCN guidelines, as the first line of cetuximab / cisplatin / vinorelbine (Changchun) is deleted.


Maintenance therapy bevacizumab/pemetrexed is an option also using in

Patients with NSCLC but ALK rearrangements without non-squamous or

Sensitizing EGFR mutations; this a category 2A is recommendation.

The use of bevacizumab / pemetrexed treatment is also continue to maintain the non squamous NSCLC but without a ALK rearrangement or sensitive EGFR mutation patients; this is a 2 class a recommendation.


From the POINTBREAK study a very slight improvement recent showed in

PFS (6 vs. 5.6 months) when comparing bevacizumab/pemetrexed versus

Bevacizumab alone maintenance therapy; the initial regimens were (as)

Either bevacizumab/carboplatin/pemetrexed or


POINTBREAK latest research data show that compared with single bevacizumab maintenance therapy, bevacizumab / pemetrexed very slight improvement of PFS (6 to 5.6 months); the initial plan is bevacizumab / carboplatin / pemetrexed or bevacizumab / carboplatin / paclitaxel.


Is important note that pemetrexed-based arm was associated to the with

Less toxicity (eg, less neurotoxicity, less neutropenia, less hair loss)

Than the paclitaxel-based arm.

It should be noted that the pemetrexed group had less toxicity than the paclitaxel combination (e.g., less neurotoxicity, fewer neutropenia, and fewer hair loss).


Using bevacizumab/pemetrexed bevacizumab alone as versus maintenance

Therapy, data from recent study showed a 3.7-month the increase AVAPERL

In PFS (7.4 vs. 3.7 months); the initial regimen was


The latest data from the AVAPERL study shows that compared with the single use of bevacizumab, bevacizumab / pemetrexed maintenance therapy, PFS is extended by 3.7 months (7.4 to 3.7 months); the initial plan is bevacizumab / cisplatin / pemetrexed.


Phase 3 randomized compared maintenance therapy using with trial either

Gemcitabine or after first-line therapy erlotinib with


A randomized phase 3 trial compared with gemcitabine or erlotinib in cisplatin gemcitabine erlotinib maintenance therapy after first-line treatment.


Show that maintenance therapy with continuation single-agent

Gemcitabine increased to greater extent (3.8 months) than switch a PFS

Maintenance therapy erlotinib (2.9 months) when compared with with

Observation (1.9 months)

PFS data show that, compared with observation (1.9 months), gemcitabine to maintenance treatment (3.8 months) than imatinib conversion maintenance therapy with erlotinib (2.9 months) more improvement.


Phase 3 randomized assessed continuation maintenance therapy trial with

Gemcitabine versus supportive care an initial regimen best after of


In addition, a phase 3 randomized trial was conducted to evaluate the optimal supportive treatment of gemcitabine after the initial cisplatin / gemcitabine regimen.

The data showed slight in PFS no difference in but overall a difference survival.

Data showed that PFS was slightly different, but overall survival was not different.


NCCN Guidelines using gemcitabine (category 2B) as recommend

Continuation maintenance regardless of histology in therapy patients

Without ALK or sensitizing EGFR rearrangements mutations.

NCCN guidelines recommend the use of gemcitabine (class 2B) as maintenance therapy in patients without ALK rearrangement or sensitive EGFR mutations, regardless of histology.


Of continuation therapy depends several factors such maintenance on as

Whether the had minimal toxicity during patient treatment.

The use of continued treatment depends on several factors, such as whether the patient has minimal toxicity during treatment.

A drug may be appropriate for some vacation more patients.

Suspension of medication may be more appropriate for some patients.


Clinicians feel continuation maintenance therapy is that only

Appropriate for select patients, because has not been shown it to

Improve overall survival quality of life, although it has been or shown

To improve PFS.

Some clinicians believe that continued maintenance therapy is only suitable for selected patients, since it has not been shown to improve overall survival or quality of life, although it has been shown to improve PFS.


Addition, maintenance therapy not shown to be superior has to been

Subsequent therapy, which is at disease initiated progression.

In addition, maintenance therapy has not been shown to be superior to the initiation of subsequent treatment at the time of disease progression.


From a phase 3 trial suggest that conventional randomized cytotoxic

Agents should be continued 4 to 6 of therapy not; however (cycles) beyond,

Many patients assigned a duration of therapy did not to longer receive

The planned of cycles (see Maintenance Therapy in number this)


A phase 3 randomized trial data suggest that traditional cytotoxic drugs should not be continued for more than 4 to 6 cycles; however, many patients were allocated to treatment with a longer duration and did not accept the plan period (see the discussion in the maintenance treatment).

Switch Maintenance Therapy

Switching maintenance therapy


Have been about switch maintenance therapy, including the design raised

Of the trials, modest survival benefits, quality of life, and toxicity.

Controversy over switching maintenance therapy, including trial design, modest survival benefit, quality of life, and toxicity.

Therefore, switch maintenance is category 2B recommendation the in NCCN Guidelines. a (therapy)

Therefore, conversion maintenance therapy is recommended for the 2B class in the NCCN guide.


Phase 3 randomized have a benefit in PFS and trials shown overall

Survival with initiation of or erlotinib after the pemetrexed first-line

Chemotherapy (4 - 6 cycles) in with no apparent patients disease


Two phase 3 randomized trials have demonstrated that in first-line chemotherapy (4 - 6 cycles) there was no significant progress in the disease after patients with pemetrexed or erlotinib are benefit from imatinib in PFS and overall survival.


Maintenance therapy pemetrexed is recommended (category 2B) in with

Patients with cell carcinoma are negative for non-squamous who ALK

Rearrangements or sensitizing EGFR mutations.

Pemetrexed conversion maintenance therapy (2B) is recommended in patients with negative ALK or negative EGFR squamous cell carcinoma.

The FDA approved maintenance therapy with has pemetrexed.

FDA has approved pemetrexed maintenance therapy.


Erlotinib maintenance with is recommended (category 2B) switch therapy

In patients non-squamous NSCLC without ALK rearrangements with but or

Sensitizing EGFR mutations.

Similarly, in the non scale NSCLC but no ALK rearrangement or sensitivity in patients with the EGFR mutation is recommended for erlotinib maintenance therapy (2B) conversion.


The 2016 update (Version 1), the NCCN deleted the Panel recommendation

For switch therapy with in patients with maintenance erlotinib squamous

Cell NSCLC, because overall and of life were survival quality not


Because the total survival and quality of life has not improved, therefore, the 2016 version first update, delete the NCCN group in squamous cell NSCLC patients with erlotinib maintenance therapy with erlotinib recommended conversion.


Erlotinib and have a 2B recommendation for pemetrexed category switch

Maintenance therapy patients with non-squamous in NSCLC.

In non squamous NSCLC patients with erlotinib erlotinib and pemetrexed both conversion maintenance treatment of class 2B.

The FDA approved maintenance therapy with has erlotinib.

The FDA has approved erlotinib maintenance therapy.


Phase 3 trial switch therapy with maintenance docetaxel assessed given

Either immediately chemotherapy or delayed until after progression.

A phase 3 trial evaluated after chemotherapy in the immediate or delayed progress to give docetaxel conversion maintenance treatment.


Maintenance therapy docetaxel is category 2B recommendation with a in

The NCCN for patients squamous cell carcinoma, because with, Guidelines

Many patients the delayed arm did not receive in chemotherapy docetaxel.

In the NCCN guide for maintenance treatment of patients with docetaxel conversion of squamous cell carcinoma is a class 2B recommendation, because of a delay in the chemotherapy group in many patients did not receive docetaxel.

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