Line of therapy
4 valuesReaders (Gemini 3.8 Flash, GPT-6 Luna)Jev checkAdjudicatorLine filters
Field
line_of_therapy on every row. Jev agrees with the published value on 94% of 647 rows. “Readers agree” compares the two readers before adjudication. Select a value for its rows, or a Jev answer for the rows where it differs.11. `treatment_phase` is OPTIONAL — set it ONLY when the SmPC explicitly names one of the five phases. Default is null. Do NOT use it as a catch-all for "non-perioperative" therapy.
- SmPC says "adjuvant treatment" → treatment_phase="adjuvant".
- SmPC says "neoadjuvant treatment" → treatment_phase="neoadjuvant".
- SmPC says "induction treatment" → treatment_phase="induction" (most often hematology, e.g. bortezomib in transplant-eligible MM).
- SmPC says "consolidation" → treatment_phase="consolidation" (e.g. brentuximab post-ASCT in Hodgkin lymphoma).
- Treatment of locally advanced or limited-stage disease "whose disease has not progressed following (platinum-based) chemoradiation" is consolidation after definitive chemoradiation, even without the word: treatment_phase="consolidation", line_of_therapy="any".
- SmPC says "maintenance" → treatment_phase="maintenance" (e.g. rituximab in follicular lymphoma).
- SmPC says "treatment of metastatic X" with no phase word → treatment_phase=null.
- A regimen that continues as maintenance in the same sentence is split by phase (rule 12a).13. `line_of_therapy` counts the minimum number of prior lines of systemic therapy that the wording guarantees: 0 → 1L, at least 1 → 2L, at least 2 → 3L+. A 2L row means "after one or more prior lines".
- "first-line", "previously untreated", "treatment-naive", "no prior systemic therapy (or chemotherapy) for metastatic disease" → 1L.
- "second-line", "after one prior line", "after failure of prior platinum-based therapy", "relapsed", "refractory", "relapsed or refractory", "previously treated", "pretreated", "after prior therapy", "progressed on or after", "platinum-resistant", "platinum-sensitive relapsed" → 2L.
- An upper bound ("no more than two prior chemotherapy regimens", "one or two prior regimens") → 2L; write the cap into prior_therapy.
- "after at least two prior therapies", "after ≥2 prior lines", "third-line or later", "heavily pretreated", "after multiple prior therapies" → 3L+.
- Autologous stem cell transplant (ASCT): in lymphomas, salvage chemotherapy plus ASCT is the second line, so "relapsed or refractory after (failed) ASCT" → 3L+, and post-ASCT consolidation without relapse ("at increased risk of relapse or progression following ASCT") → 2L. In multiple myeloma, induction, ASCT, consolidation and maintenance together are the first line (IMWG) → 1L.
- Branches with different counts in one sentence → one row at the lowest count (rule 1); split only when one branch is untreated (1L) and another pretreated.
- Naivety to one drug class ("EGFR TKI-naive", "BRAF inhibitor-naive", "not previously treated with endocrine therapy") does not set a line → any, unless other words fix it; write e.g. "No prior EGFR TKI" or "No prior endocrine therapy" into prior_therapy.
- A disease state is not a prior line. Refractoriness to radioactive iodine (thyroid cancer) and castration resistance ("castration-resistant", "after failure of androgen deprivation therapy") describe the disease; count only systemic therapy given for it. Metastatic castration-resistant prostate cancer before chemotherapy → 1L; after docetaxel → 2L. RAI-refractory thyroid cancer with no prior systemic therapy → 1L.
- A prior therapy the label waives guarantees nothing: "previously treated with an anthracycline and a taxane … unless patients were not suitable for these treatments", "previously treated with, or are not considered candidates for, available therapies" → any. Keep the wording in prior_therapy.
- Count the lines given for advanced (unresectable or metastatic) disease. Neoadjuvant or adjuvant therapy counts only when the label ties it to early relapse ("relapsed during or within 6 months of completing adjuvant therapy"). "Two or more prior systemic therapies, at least one of them for advanced disease" → 2L. A prior regimen "in any setting" may have been neoadjuvant or adjuvant → any. Prior regimens whose setting the label leaves open count as lines ("at least 2 prior anti-HER2 treatment regimens" → 3L+).
- Radiotherapy is not systemic therapy: "at least one prior radiation and/or chemotherapy treatment" → any.
- A switch within first-line therapy before progression ("upon detection of an ESR1 mutation and without disease progression during first-line endocrine therapy in combination with a CDK4/6 inhibitor") → 1L, prior_therapy "During first-line endocrine therapy + CDK4/6 inhibitor, before progression".
- Neoadjuvant and adjuvant rows → any. Induction, consolidation and maintenance rows take the line of the therapy they belong to when the text says so ("newly diagnosed", "following first-line chemotherapy" → 1L; "relapsed", "platinum-sensitive relapsed" → 2L); otherwise any.
- If no line information at all → "any".Line of therapy for THIS ROW: the minimum number of prior lines the wording guarantees. Neoadjuvant and adjuvant rows are 'any'; induction, consolidation and maintenance rows take the line of the therapy they belong to.
| Value | Definition (as Jev sees it) | Rows | Jev agrees | Jev answered instead |
|---|---|---|---|---|
1L | first-line, previously untreated, treatment-naive, no prior systemic therapy for metastatic disease; multiple myeloma induction, ASCT and maintenance; castration-resistant prostate cancer before chemotherapy, or radioactive-iodine-refractory thyroid cancer, with no prior systemic therapy for it (castration resistance and RAI refractoriness are disease states, not lines); a switch during first-line therapy before progression | 206 | 96% | |
2L | at least one prior line for advanced disease guaranteed: second-line, after one prior therapy, relapsed, refractory, previously treated, after prior platinum, platinum-sensitive or -resistant relapse, at most two prior regimens, two or more prior therapies with at least one for advanced disease; lymphoma consolidation after ASCT | 196 | 91% | |
3L+ | at least two prior lines: after two or more prior therapies, third-line or later, heavily pretreated; lymphoma relapsed after ASCT | 47 | 100% | – |
any | no line information, naivety to one drug class only (e.g. EGFR TKI-naive), a prior therapy the label waives ('unless not suitable', 'or not candidates for'), a prior regimen 'in any setting', prior radiotherapy only, or a neoadjuvant/adjuvant row | 198 | 92% |