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Non-small cell lung cancer, squamous - null regimens

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The purpose of this page is to provide references to "null therapy" such as placebo and observation. These references provide further insight into the historical development of the treatment landscape. See the main sqNSCLC page for regimens that include active anticancer treatment.
=Maintenance after first-line therapy=
==Observation==
===Regimen===
Study 	Dates of enrollment	Evidence 	Comparator 	Comparative Efficacy
Tanaka et al. 2020 (WJOG7512L) 	2013-2017 	Phase 3 (C)	S-1 	Shorter PFS (primary endpoint)Median PFS: 1 vs 1.6 mo(HR 1.82, 95% CI 1.25-2.70)
Spigel et al. 2020 (ABOUND.sqm)	2014-2017 	Phase 3 (C)	nab-Paclitaxel	Did not meet primary endpoint of PFSMedian PFS: 2.6 vs 3.12 mo(HR 1.18, 95% CI 0.84-1.64)
Gelsomino et al. 2024 (EDEN) 	2017-09 to 2020-08 	Phase 3 (C)	Nivolumab 	Did not meet primary endpoint of OSMedian OS: 18.8 vs 14.9 mo(HR 0.92, 95% CI 0.62-1.35)
No further treatment after first-line therapy.
====Preceding treatment====
*WJOG7512L: Carboplatin & S-1 induction
*ABOUND.sqm: First-line Carboplatin & nab-Paclitaxel x 4
*EDEN: First-line platinum-based chemotherapy
===References===
#WJOG7512L: Tanaka K, Morita S, Ando M, Yokoyama T, Nakamura A, Yoshioka H, Ishiguro T, Miura S, Toyozawa R, Oguri T, Daga H, Ko R, Bessho A, Tachihara M, Iwamoto Y, Hirano K, Nakanishi Y, Nakagawa K, Yamamoto N, Okamoto I. A randomized phase 3 study of maintenance therapy with S-1 plus best supportive care versus best supportive care after induction therapy with carboplatin plus S-1 for advanced or relapsed squamous cell carcinoma of the lung (WJOG7512L). Cancer. 2020 Aug 15;126(16):3648-3656. Epub 2020 Jun 2. link to original article dosing details in manuscript have been reviewed by our editors EuroPMC UMIN000010396
# ABOUND.sqm: Spigel DR, Jotte RM, Aix SP, Gressot L, Morgensztern D, McCleod M, Socinski MA, Daniel D, Juan-Vidal O, Mileham KF, West H, Page R, Reinmuth N, Knoble J, Chen T, Bhore R, Wolfsteiner M, Ong TJ, Gridelli C, Thomas M; ABOUND.sqm Investigators. Nanoparticle Albumin-bound Paclitaxel Plus Carboplatin Induction Followed by Nanoparticle Albumin-bound Paclitaxel Maintenance in Squamous Non-Small-cell Lung Cancer (ABOUND.sqm): A Phase III Randomized Clinical Trial. Clin Lung Cancer. 2021 Jan;22(1):6-15.e4. Epub 2020 Sep 18. link to original article EuroPMC NCT02027428
# EDEN: Gelsomino F, Boni L, Tiseo M, Ricciardi S, Rocco D, Cortinovis DL, Proietto M, Cogoni A, Pasello G, Camerini A, Sperandi F, Colantonio I, Metro G, Mazzoni F, Baldini E, Veccia A, Bennicelli E, Cecilia Bettini A, Tognetto M, Ardizzoni A. An open-label, randomized phase III study of early switch maintenance vs delayed second-line nivolumab in advanced stage squamous non-small cell lung cancer (NSCLC) patients after standard first-line platinum-based chemotherapy-EDEN trial GOIRC 04-2016. Lung Cancer. 2024 Dec;199:108059. link to original article link to EuroPMC NCT03542461
Category:Non-small cell lung cancer regimens
Category:Null regimens
Category:Histology-specific pages
Category:Non-small cell lung cancers
NovoTTF-100A system (Optune)

==General information==
Class/mechanism: External portable device which delivers electric tumor treating fields (TTFields) via insulated transducer arrays placed on the patient's skin close to glioblastoma multiforme (GBM) tumors. TTFields affect dividing cells by two main mechanisms. First, they disrupt microtubule spindle formation during anaphase, in which tubulin, a highly electrically polar molecule, normally forms polymers. Exposure to TTFields prevents tubulin from being able to align properly and promotes depolymerization of mitotic spindles. Second, the TTFields disrupt the cleavage plane between the two daughter cells during late telophase. These actions halt cell division, cause abnormal spindle formation, disrupt regular chromosome separation, and result in apoptosis.NovoTTF-100A system (Optune) FDA summary of safety and effectiveness data (SSED) NovoTTF-100A system (Optune) FDA summary of safety and effectiveness data (SSED) (locally hosted backup)NovoTTF-100A FDA neurological device information NovoTTF-100A FDA neurological device information (locally hosted backup)NovoTTF-100A manufacturer's websiteFDA medical device pageOptune manufacturer's website
Route: external portable device
Extravasation: n/a
==Diseases for which it is used==
*Glioblastoma
*Malignant pleural mesothelioma
==Patient drug information==
*NovoTTF-100A device (Optune) instructions for useNovoTTF-100A device (Optune) instructions for use
*NovoTTF-100A FDA neurological device information PDF pages 208-259NovoTTF-100A FDA neurological device information PDF pages 208-259
==History of changes in FDA indication==
*2011-04-08: FDA approved "to treat adults with glioblastoma multiforme (GBM) that recurs or progresses after receiving chemotherapy and radiation therapy."NovoTTF-100A system FDA overview of information
*2015-10-05: FDA approved expanded indication "as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM)...for the treatment of adult patients with newly diagnosed, supratentorial glioblastoma following maximal debulking surgery and completion of radiation therapy together with concomitant standard of care chemotherapy."
==Also known as==
*Code name: PMA P100034/S013 
*Brand name: Optune
==References==
Category:Devices
Category:Locally delivered therapies
Category:Glioblastoma medications
Category:Malignant pleural mesothelioma medications
ONS guidelines

This page will be a gathering place for the Oncology Nursing Society (ONS) guidelines that do not clearly fit under a disease-specific page.
Given the rapid change in evidence in many areas of hematology/oncology, readers are encouraged to consider any guideline published 5+ years ago to be for historical purposes, only.
=Guidelines=
==Constipation==
* 2020: Rogers et al. ONS Guidelines™ for opioid-induced and non-opioid-related cancer constipation. EuroPMC
==Hot Flashes==
* 2020: Kaplan et al. ONS Guidelines™ for cancer treatment-related hot flashes in women with breast cancer and men with prostate cancer. EuroPMC
==Lymphedema==
* 2020: Armer et al. ONS Guidelines™ for cancer treatment-related lymphedema. EuroPMC
==Medication Adherence==
* 2022: Belcher et al. ONS Guidelines™ to support patient adherence to oral anticancer medications. EuroPMC
==Radiodermatitis==
* 2020: Gosselin et al. ONS Guidelines™ for Cancer Treatment–Related Radiodermatitis EuroPMC
==Skin Toxicity==
* 2020: Williams et al. ONS Guidelines™ for cancer treatment-related skin toxicity. EuroPMC
Category:Guideline pages
Obecabtagene autoleucel (Aucatzyl)

==Mechanism of action==
From the NCI Drug Dictionary: A preparation of autologous T lymphocytes that have been genetically modified and transduced with a lentiviral vector expressing a second-generation chimeric antigen receptor (CAR), CAT-41BBz CAR, targeting the tumor-associated antigen (TAA) CD19, with potential immunostimulating and antineoplastic activities. Upon administration, obecabtagene autoleucel target and bind to CD19-expressing tumor cells. This results in a cytotoxic T-lymphocyte (CTL) response against CD19-expressing tumor cells and tumor cell lysis. CD19, cluster of differentiation 19, is a B-cell-specific cell surface antigen overexpressed in B-cell lineage tumors. The CAT-41BBz CAR has a faster off-rate compared with FMC63-41BBz CAR. This may minimize cytokine release and reduce toxicities, and enhance persistence of the CAR T cells.
==History of changes in FDA indication==
*2024-11-08: Approved for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). (Based on FELIX)
==Also known as==
*Code name: AUTO-1
*Generic name: obe-cel
*Brand name: Aucatzyl
Category:Anti-CD19 CAR T-cells
Category:Intravenous medications
Category:B-cell acute lymphoblastic leukemia medications
Category:FDA approved in 2024
Oblimersen (Genasense)

==Mechanism of action==
From the NCI Drug Dictionary: The sodium salt of a phosphorothioate antisense oligonucleotide targeted to the initiation codon region of mRNA for the anti-apoptotic gene Bcl-2. Oblimersen inhibits Bcl-2 mRNA translation, which may result in decreased expression of the Bcl-2 protein and tumor cell apoptosis. This agent may enhance the efficacy of standard cytotoxic chemotherapy.
==Also known as==
*Code name: G-3139
*Brand name: Genasense
Category:Drugs
Category:Oral medications
Category:Bcl-2 translation inhibitors
Category:Chronic lymphocytic leukemia medications (investigational)
Category:Investigational drugs
Octreotide (Sandostatin)

==General information==
Class/mechanism: Long-acting octapeptide that suppresses multiple hormones and has physiologic actions similar to somatostatin. It suppresses LH response to GnRH, reduces splanchnic blood flow, and inhibits release of serotonin, gastrin, vasoactive intestinal peptide, secretin, motilin, pancreatic polypeptide, growth hormone, IGF-I (somatomedin C), glucagon, insulin, and TSH.Octreotide (Sandostatin) package insert Octreotide (Sandostatin) package insert (locally hosted backup)Sandostatin manufacturer's website
Route: SC, IV
Extravasation: no information
For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, or the prescribing information. 
==Diseases for which it is used==
*Neuroendocrine tumor
*Pancreatic NET
*Thymoma
==Patient drug information==
*Octreotide (Sandostatin) patient drug information (Chemocare)Octreotide (Sandostatin) patient drug information (Chemocare)
*Octreotide (Sandostatin) patient drug information (UpToDate)Octreotide (Sandostatin) patient drug information (UpToDate)
==History of changes in FDA indication==
*1988-10-21: Initial approval for treatment of chronic and severe diarrhea and flushing episodes associated with carcinoid tumors and vasoactive intestinal peptide-secreting tumors (VIPomas). (No supporting studies are cited)
==History of changes in EMA indication==
*1995-06-23: EURD
==Also known as==
*Code name: SMS-201-995
*Generic names: octreotide immediate release, octreotide IR, octreotide acetate
*Brand names: Longastatina, Mycapssa, Octrestatin, Octride, Okeron, Proclose, Samilstin, Sandostatin, Sandostatina, Sandostatine
==References==
Category:Drugs
Category:Subcutaneous medications
Category:Intravenous medications
Category:Somatostatin analogs
Category:Neuroendocrine tumor medications
Category:Pancreatic NET medications
Category:Thymoma medications
Category:FDA approved in 1988
Category:EMA approved in 1995
Octreotide LAR (Sandostatin LAR)

==General information==
Class/mechanism: Long-acting dosage form of Octreotide (Sandostatin). The LAR depot formulation consists of octreotide contained within biodegradable glucose star polymer microspheres; octreotide is gradually released as the polymer degrades via hydrolysis. Octreotide (Sandostatin) is a long-acting octapeptide that suppresses multiple hormones and has physiologic actions similar to somatostatin. It suppresses LH response to GnRH, reduces splanchnic blood flow, and inhibits release of serotonin, gastrin, vasoactive intestinal peptide, secretin, motilin, pancreatic polypeptide, growth hormone, IGF-I (somatomedin C), glucagon, insulin, and TSH.Octreotide LAR (Sandostatin LAR) package insert Octreotide LAR (Sandostatin LAR) package insert (locally hosted backup)Sandostatin LAR manufacturer's website
Route: IM
Extravasation: n/a
For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, or the prescribing information. 
==Diseases for which it is used==
*Neuroendocrine tumor
*Pancreatic NET
==History of changes in PMDA indication==
*2011-11-25: New additional indication and a new dosage for the treatment of gastrointestinal neuroendocrine tumor.
==Patient drug information==
*Octreotide (Sandostatin) patient drug information (Chemocare)Octreotide (Sandostatin) patient drug information (Chemocare)
*Octreotide (Sandostatin) patient drug information (UpToDate)Octreotide (Sandostatin) patient drug information (UpToDate)
==Also known as==
*Generic names: octreotide acetate for injectable suspension, octreotide long-acting release
*Brand names: Longastatina LAR, Sandostatin LAR, Sandostatin LAR Depot, Sandostatina LAR, Sandostatine LAR
==References==
Category:Drugs
Category:Intramuscular medications
Category:Somatostatin analogs
Category:Neuroendocrine tumor medications
Category:Pancreatic NET medications
Category:FDA approved in 1998
Olanzapine (Zyprexa)

==Mechanism of action==
Atypical antipsychotic with antiemetic properties, likely through its effect on dopamine receptors. No known antineoplastic properties.
==History of changes in PMDA indication==
*2017-12-25: New additional indication and a new dosage indicated for the treatment of gastrointestinal symptoms (nausea and vomiting) associated with the administration of antineoplastic drugs (cisplatin, etc.).
==Also known as==
*Brand name: Zyprexa
Category:Drugs
Category:Intramuscular medications
Category:Oral medications
Category:Emesis prevention
Category:Dopamine receptor antagonist
Category:Antipsychotic
Category:FDA approved in 1996
Olaratumab (Lartruvo)

Note: as of April 2019, the manufacturer has decided to discontinue the product after the confirmatory RCT was negative.
=General information=
Class/mechanism: Human IgG1 antibody that blocks the activity of platelet-derived growth factor receptor alpha (PDGFR-α). Olaratumab prevents binding of PDGF-AA and -BB ligands to PDGFR-α and blocks PDGF-AA, -BB, and -CC-induced receptor activation and downstream PDGFR-α pathway signaling, including the MAPK and PI3K pathways. PDGFR-α is a receptor tyrosine kinase expressed on mesenchymal origin cells, and signaling through PDGFR-α is involved in cell growth, chemotaxis, and mesenchymal stem cell differentiation.Olaratumab (Lartruvo) package insert Olaratumab (Lartruvo) package insert (locally hosted backup)Lartruvo manufacturer's websiteNCI Drug Dictionary entry for olaratumab
Route: IV
Extravasation: no information
For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, or the prescribing information.
==Diseases for which it was used==
*Soft tissue sarcoma
==Patient drug information==
*Brief patient counseling information can be found in the Olaratumab (Lartruvo) package insert 
==History of changes in FDA indication==
===Soft tissue sarcoma - WITHDRAWN===
*2016-10-19: Accelerated approval for the treatment of patients with soft tissue sarcoma (STS) not amenable to curative treatment with radiotherapy or surgery and with a histologic subtype for which an anthracycline-containing regimen is appropriate. (Based on CP15-0806)
**2020-02-25: Accelerated approval withdrawn. (Based on ANNOUNCE)
==History of changes in EMA indication==
*2016-11-09: Initial authorization as Lartruvo. Lartruvo is indicated in combination with doxorubicin for the treatment of adult patients with advanced soft tissue sarcoma who are not amenable to curative treatment with surgery or radiotherapy and who have not been previously treated with doxorubicin.
*2019-04-26: Approval withdrawn. (Based on ANNOUNCE)
==History of changes in Health Canada indication==
*2017-11-23: Initial notice of compliance with conditions
*2020-10-08: Approval withdrawn.
==Also known as==
*Code names: LY-3012207, IMC-3G3
*Brand name: Lartruvo
==References==
Category:Drugs
Category:Intravenous medications
Category:Anti-PDGFR antibodies
Category:Soft tissue sarcoma medications (historic)
Category:FDA approved in 2016
Category:EMA approved in 2016
Category:Health Canada approved in 2017
Category:Discontinued drugs
Category:EMA withdrawn in 2019
Category:FDA withdrawn in 2020
Category:Health Canada withdrawn in 2020
Olive View/UCLA Medical Center Hematology Oncology Fellowship

For information about other programs, please visit the Hematology Oncology Fellowship Programs Directory.
People affiliated with this program are cordially invited to add additional information.
"The program’s goal is to provide a comprehensive, rigorous clinical training experience in the fields of hematology and oncology, with an emphasis on evidence-based clinical care. Throughout their training, fellows will encounter a broad range of clinical disease on their rotations and electives. In addition they will also engage in scholarly research projects and performance improvement initiatives at each of the medical centers in this program. By the end of their fellowship, our fellows will be well-prepared in diagnosing, treating, and caring for a broad range of complex hematologic and oncologic conditions in a diverse patient population across a variety of health care systems."
==Basic information==
Name: UCLA-Olive View Hematology-Oncology Fellowship
Fellowship program website: https://www.uclaoliveview.org/hemonc/
ACGME ID: 1550513008
===Leadership===
*Program Director: Jeffrey M. Miller, MD
*Associate Program Director: Phillis Wu, MD
*Cedars-Sinai Medical Center Site Coordinator: Robert Figlin, MD
*Kaiser Permanente Los Angeles Medical Center Site Coordinator: Karen Kwan, MD
===Fellowship Coordinator===
Bill Heath
UCLA-Olive View Hematology-Oncology Fellowship
Department of Medicine, Room 2B-182
14445 Olive View Drive
Sylmar, CA 91342
Email: BHeath@dhs.lacounty.gov
Phone: (818) 364-3205
Fax: (818) 364-4573
General:
Email: hemonc@uclaoliveview.org
Phone: (818) 364-3205
==Application process and requirements==
https://www.uclaoliveview.org/hemonc/apply/
===Process===
*Applications accepted starting on: 
*Application deadline: 
*Applications submitted through ERAS
===Requirements===
==Statistics==
*Number of fellowship positions available per year: 3 to 4
*Board certification eligibility upon fellowship completion: Hematology and Oncology
*Length of fellowship: 3 years
==Schedule==
https://www.uclaoliveview.org/hemonc/fellowship-program/curriculum/
===Year 1===
===Year 2===
===Year 3===
==Affiliated medical facilities==
*Olive View-UCLA Medical Center Department of Medicine, 2B-182 14445 Olive View Drive Sylmar, CA 91342
*Cedars-Sinai Medical Center 8700 Beverly Blvd AC1072 Los Angeles, CA 90048
*Kaiser Permanente Los Angeles ("Sunset") Medical Center 4867 Sunset Boulevard Los Angeles, CA 90027
*Elective rotations available at the VA West Los Angeles Medical Center, Ronald Reagan UCLA Medical Center and local private Hematology/Oncology and Radiation Oncology practices.
==Testimonials==
Testimonials from fellows are welcome. If you are a current or former fellow and would be willing to answer questions from applicants, please tell us and sign up for a free account so you can be listed here. Your email address will not be shared--messages will be sent through the site directly to the email address you provide us.
==Notable faculty==
To be listed by fellowship program.
Category:Hematology & Oncology fellowship programs
Olutasidenib (Rezlidhia)

==General information==
From the NCI Drug Dictionary: An orally available inhibitor of isocitrate dehydrogenase type 1 (IDH1; IDH-1; IDH1 [NADP+] soluble) with a mutation at arginine (R) 132, IDH1(R132), with potential antineoplastic activity. Upon administration, olutasidenib specifically inhibits IDH1(R132), thereby inhibiting the formation of the oncometabolite 2-hydroxyglutarate (2HG) from alpha-ketoglutarate (a-KG). This prevents 2HG-mediated signaling and leads to both an induction of cellular differentiation and an inhibition of cellular proliferation in tumor cells expressing IDH(R132).
==Diseases for which it is established==
*IDH1-mutated AML
==History of changes in FDA indication==
===Acute myeloid leukemia===
* 2022-12-01: Granted approval for adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation. (Based on 2102-HEM-101)
==Also known as==
*Code name: FT-2102
*Brand name: Rezlidhia
Category:Drugs
Category:Oral medications
Category:Mutation-specific medications
Category:IDH1 inhibitors
Category:Acute myeloid leukemia medications
Category:FDA approved in 2022
Olverembatinib (HQP-1351)

==Mechanism of action==
Third-generation TKI
==Diseases for which it is used==
*Chronic myeloid leukemia
==History of changes in NMPA indication==
*2021-11: Initial conditional approval for the treatment of adult patients with TKI-resistant CML-CP or CML-AP harboring the T315I mutation as confirmed by a validated diagnostic test. (Based on HQP1351CC202 & HQP1351CC203)
*2023-11-17: Approved for the treatment of adult patients with chronic-phase chronic myeloid leukemia (CML-CP) resistant and/or intolerant of first-and second-generation tyrosine kinase inhibitors (TKIs). (Based on HQP1351CC203)
==Also known as==
*Code name: HQP-1351
Category:Drugs
Category:Oral medications
Category:Mutation-specific medications
Category:Bcr-Abl inhibitors
Category:Chronic myeloid leukemia medications
Category:NMPA approved in 2021
Category:Stub